High-flow nasal cannula (HFNC) was associated with a lower intubation rate compared with conventional oxygen therapy (COT) in patients hospitalized with COVID-19, according to a study in Therapeutic Advances in Respiratory Disease.

The results are from a systematic review and meta-analysis of clinical trials comparing intubation risk in patients with COVID-19-related acute hypoxemic respiratory failure who used HFNC vs COT.

The researchers searched for relevant studies in PubMed, EMBASE, Web of Science, Scopus, ClinicalTrials.gov, medRxiv, BioRxiv, and the Cochrane Central Register of Controlled Trials from January 1, 2020, to October 1, 2022. Eligible randomized controlled trials (RCTs) and observational studies included adult patients (aged ≥16 years) with COVID-19-related AHRF who received HFNC compared with COT. The primary outcome was intubation rate (at 28 days or in-hospital).

The meta-analysis included 20 studies (8 RCTs and 12 observational studies), with 5732 patients.

Compared to COT, HFNC may decrease the need for tracheal intubation in patients with COVID-19-related AHRF, particularly among patients with baseline PaO2/FiO2 < 200 mm Hg and those in ICU settings.

Endotracheal intubation outcomes were reported in 17 studies (5547 patients). Results showed that HFNC may decrease the need for invasive mechanical ventilation compared with COT (odds ratio [OR], 0.61; 95% CI, 0.46-0.82; P =.0009, I2 = 75%). Subgroup analyses revealed a reduced intubation rate in the HFNC group in patients with a baseline ratio of partial pressure of arterial oxygen to fractional inspired oxygen (PaO2/FiO2) of less than 200 mm Hg (P =.0007), but not in those with baseline PaO2/FiO2 more than 200 mm Hg (P =.20). Comparable findings were observed in patients in intensive care unit (ICU) settings at enrollment (P =.005), but not in those in non-ICU settings (P =.45).

Mortality was reported in all 20 studies, and no evidence of a difference was found for HFNC compared with COT (OR, 0.84; 95% CI, 0.67-1.06; P =.15, I2 =51%).

Among other findings, increased mean PaO2/FiO2 levels were observed at 4 to 6 hours (mean difference [MD]=29.46; 95% CI, 23.31-35.61; P <.00001; I2 =0%; 2 included studies) and 24 hours (MD=30.14; 95% CI, 13.12-47.16; P =.0005; I2 =41%; 2 included studies), as well as reduced respiratory rate at 4 to 6 hours (M= −1.95; 95% CI, −2.23 to 1.67; P <.00001; I2 =0%; 2 included studies) in the HFNC group vs the COT group.

No differences occurred between the HFNC and COT groups in days free from invasive mechanical ventilation, hospital length of stay, and ICU length of stay.

Among several limitations, the findings were based non-RCT studies as well as RCTs. Also, crossovers existed between groups in some studies and were not allowed in other studies. Furthermore, only a few studies reported accurate HFNC settings, and they were observed and recorded unsystematically.

The study authors concluded that “Compared to COT, HFNC may decrease the need for tracheal intubation in patients with COVID-19-related AHRF, particularly among patients with baseline PaO2/FiO2 < 200 mm Hg and those in ICU settings.”

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I read all kinds of nonsense on the internet about all kinds of "cures" for cancer. Most of it can be dismissed because of the lack of any reliable, robust, and repeated evidence. Recently, someone told me that eggplant extract could be used to treat skin cancer, and I dismissed it immediately. Then, I searched for evidence, and I found some.

At this point, I'm not convinced that eggplant (or aubergines, if you live in the UK or Ireland) has any effect on skin cancer. Furthermore, most medical societies that focus on cancer also are unconvinced. However, there is some non-clinical evidence that it may work, so let's take a look at this research and see if it has any clinical effect.

Research on eggplant and cancer

The paper I'll discuss, published online in 2013 in WebmedCentral Cancer, seemed to indicate that a topical cream that contained an eggplant extract called BEC5 could treat skin cancer (melanoma or basal cell carcinoma). Now this paper is published on a website, not in a reputable journal. In fact, the "paper" doesn't even show up on PubMed, which lists nearly every scientific article published over the past few decades.

This paper claimed that the BEC5 extract from eggplants could kill skin cancer cells. This is an in vitro study, meaning the extract was put in cells in a literal petri dish. The researchers provided no evidence that it might work on a living, breathing human being.

Furthermore, and this is important, I could find no research that repeated this study anywhere. It's been a decade since this paper was published, and yet there is nothing that supports it. That raises my skeptical radar by a lot.

In science-based medicine, a breakthrough clinical therapy needs to be both biologically plausible and supported by a preponderance of evidence. There may be some plausibility, but there is no clinical evidence that supports this.

In cancer research, scientists will try all kinds of compounds to treat cancer, usually in cell culture or in some animal models (like mice and rats). But there's an old joke about this kind of research — we've cured cancer in mice 100,000 times. Yet, less than 10% of drugs tested in cell or animal models ever get FDA approval for humans, because they mostly fail in clinical trials.

I could find no other clinical research that supported the use of BEC5 or any other aubergine extract in treating melanoma or basal cell carcinoma, the most common type of skin cancer in the USA.

In fact, a recent review article of "herbal remedies" for skin cancer concluded that:

Online advertising may tempt patients to use botanical agents while citing efficacy found in preclinical studies. However, many agents lack strong clinical evidence of efficacy. Dermatologists must be aware of common herbal alternatives for skin cancer treatment to maintain effective patient communication and education.

Furthermore, major medical societies such as the Skin Cancer Foundation, American Academy of Dermatology, and the American Cancer Society make no recommendations about aubergines or eggplants. If it really worked to treat melanomas or basal cell carcinomas, they would be promoting it widely.

Summary

Once again, internet quacks pull a minor study, that wasn't published in a major, respected journal, and then try to claim that this extract works in curing skin cancer. But it does not do that, not because I believe it does not, but because there is no evidence supporting that claim.

Furthermore, claims such as this one are not a substitute for evidence-based medical treatments. Always prioritize professional medical advice when dealing with cancer or any health condition. Skin cancers can be treated quickly if caught early. If you rub eggplant skins on an early cancer, you won't do anything but delay treatment. And that's the most dangerous part of this.

Because of the lack of evidence, I can only conclude that there is no evidence supporting the use of eggplants (or aubergines) or extracts from them in treating skin cancers. Go see a physician for suspected skin cancer, the outcomes will be much better.

Citations

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In the relentless battle against severe asthma, a condition that has ensnared millions worldwide in its breath-stealing grip, a ray of hope shines from Down Under. Australian researchers have unveiled a groundbreaking discovery that could redefine the therapeutic landscape for those wrestling with this chronic respiratory nemesis. At the heart of this revelation lies the identification of beta common cytokines as pivotal players in the inflammation and scarring that characterizes severe and steroid-resistant asthma. Spearheaded by the University of South Australia, this study not only illuminates the pathogenesis of asthma but also introduces trabikihart, a human antibody, as a potential game-changer in treatment paradigms.

The Culprits Unveiled: Beta Common Cytokines

The recent study amplifies our understanding of asthma's underlying mechanisms, spotlighting beta common cytokines as key orchestrators of the inflammatory and scarring processes in the airways. This insight challenges the conventional treatment approach, which predominantly targets single inflammatory molecules. Damon Tumes, a lead researcher, emphasizes the inadequacy of such singularly focused therapies and advocates for a more holistic strategy. By zeroing in on multiple inflammatory cytokines simultaneously, the novel antibody trabikihart heralds a promising horizon for those afflicted by severe asthma forms.

Trabikihart: A Beacon of Hope

The introduction of trabikihart as a therapeutic contender is particularly timely, given the alarming uptick in asthma-related fatalities reported by the National Asthma Council Australia. With 467 deaths in 2022, the highest toll since 2017, the urgency for efficacious treatments has never been more palpable. Trabikihart’s ability to block the detrimental effects of beta common cytokines could represent a significant leap forward, offering a lifeline to those for whom conventional treatments fall short. This advancement is not just a testament to scientific ingenuity but also a beacon of hope for millions gasping for relief.

Looking Ahead: Implications and Challenges

While the horizon looks promising, the journey from discovery to bedside is fraught with hurdles. The transition from theoretical breakthrough to practical treatment entails rigorous clinical trials, regulatory approvals, and ultimately, accessibility considerations. Moreover, the financial implications of introducing a novel therapy into the market cannot be overlooked. Nevertheless, the potential to transform the lives of severe asthma sufferers worldwide fuels the drive towards surmounting these obstacles. As this research progresses, it stands as a testament to the relentless pursuit of solutions in the face of chronic disease and a reminder of the power of innovation to alter the course of medical history.



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Breathing Circuits Market Size, Share, Report and Forecast

The breathing circuits market size was valued at USD 1.01 billion in 2023, driven by pollution and lifestyle changes, which has heightened the demand for respiratory devices and their associated breathing circuits across the globe. The market size is anticipated to grow at a CAGR of 4.0% during the forecast period of 2024-2032 to achieve a value of USD 1.43 billion by 2032.

Breathing Circuits: Introduction

Breathing circuits are integral components in anesthesia and respiratory care, designed to deliver medical gases to patients safely. These circuits range from open systems, where exhaled gases are released directly into the environment, to closed systems where exhaled gases are re-circulated after carbon dioxide removal. Comprising tubing, reservoir bags, one-way valves, and often a carbon dioxide absorber, these circuits serve as the critical interface between the patient and devices like ventilators or anesthesia machines. They are essential for delivering inhaled anesthetics, supporting mechanical ventilation, and providing high-concentration oxygen. Given their pivotal role, regular inspection, maintenance, and proper cleaning are paramount to ensure patient safety and prevent equipment failure.

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Key Trends in the Global Breathing Circuits Market 

Several pivotal trends have shaped the global breathing circuits market. The escalating incidence of respiratory ailments, such as asthma and COPD, driven by pollution and lifestyle changes, has heightened the demand for respiratory devices and their associated breathing circuits. Advancements in technology have brought about sophisticated designs and materials, prioritizing patient comfort and efficient gas exchange. The rising volume of surgeries worldwide necessitating general anesthesia has further propelled the market's expansion. A noteworthy shift has been observed towards disposable circuits, driven by infection control concerns, particularly accentuated during the COVID-19 pandemic when the demand for ventilators skyrocketed. This surge underscored the significance of resilient supply chains and scalability in manufacturing.

Concurrently, emerging markets in regions like Asia Pacific and Latin America are witnessing robust growth due to enhanced healthcare infrastructure and increased health awareness. Modern breathing circuits are also increasingly being integrated with digital monitoring tools, providing real-time feedback and bolstering patient safety. However, the market navigates challenges, including regulatory hurdles and environmental concerns related to disposable medical waste. Furthermore, to amplify their reach and technological prowess, companies have been actively pursuing mergers and acquisitions.

Read Full Report with Table of Contents: www.expertmarketresearch.com/reports/breathing-circuits-market

Breathing Circuits Market Segmentation

Market Breakup by Type 

Open

Closed

Semi-Open

Market Breakup by Application

Anesthesia,

Respiratory Dysfunction

Market Breakup by End User 

Hospital

Clinics

Ambulatory Surgery Centre

Market Breakup by Region

North America

Europe

Asia Pacific

Latin America

Middle East and Africa

Breathing Circuits Market Overview

The global breathing circuits market is a dynamic sector anchored primarily in the medical device industry, catering to the essential need of delivering medical gases for patients, especially in the domains of anesthesia and respiratory care. Driven by escalating incidences of respiratory disorders, such as asthma, COPD, and sleep apnea, coupled with increasing surgical procedures necessitating general anesthesia, the demand for these circuits has seen a substantial rise. Technological innovations have played a pivotal role, introducing advanced materials and designs that enhance patient comfort and ensure efficient gas exchange. The market has also observed a tilt towards disposable circuits, underpinned by heightened concerns about cross-contamination and the critical demand dynamics during the COVID-19 pandemic.

Emerging economies, with their growing healthcare infrastructures and rising health awareness, present lucrative expansion opportunities. However, the landscape is not without challenges, with regulatory complexities and environmental concerns, especially related to disposable medical waste, being at the forefront. With a blend of established and emerging players, the market is characterized by strategic mergers and acquisitions aimed at broadening product portfolios and geographical footprints.

Breathing Circuits Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

Ambu A/S

R Bard

Fisher & Paykel Healthcare

Bio-med Devices

Teleflex Incorporated

GE Company

WillMarc Medical

Armstrong Medical

Becton, Dickson and Company

Altera

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Sanne HB van Dijk,1,2 Marjolein GJ Brusse-Keizer,1,3 Charlotte C Bucsán,2,4 Eline H Ploumen,1,5 Wendy JC van Beurden,2 Job van der Palen,3,4 Carine JM Doggen,1,6 Anke Lenferink1,2,6

1Health Technology & Services Research, Technical Medical Centre, University of Twente, Enschede, the Netherlands; 2Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, the Netherlands; 3Medical School Twente, Medisch Spectrum Twente, Enschede, the Netherlands; 4Cognition, Data & Education, Faculty of Behavioural, Management & Social Sciences, University of Twente, Enschede, the Netherlands; 5Department of Cardiology, Medisch Spectrum Twente, Enschede, the Netherlands; 6Clinical Research Centre, Rijnstate Hospital, Arnhem, the Netherlands

Correspondence: Anke Lenferink, Health Technology & Services Research, Technical Medical Centre, University of Twente, Hallenweg 5, Enschede, NH, 7522, the Netherlands, Tel +31 0534896311, Email [email protected]

Background: Due to shared symptoms, acute heart failure (AHF) is difficult to differentiate from an acute exacerbation of COPD (AECOPD). This systematic review aimed to identify markers that can diagnose AHF underlying acute dyspnea in patients with COPD presenting at the hospital.
Methods: All types of observational studies and clinical trials that investigated any marker’s ability to diagnose AHF in acutely dyspneic COPD patients were considered eligible for inclusion. An AI tool (ASReview) supported the title and abstract screening of the articles obtained from PubMed, Scopus, Web of Science, the Cochrane Library, Embase, and CINAHL until April 2023. Full text screening was independently performed by two reviewers. Twenty percent of the data extraction was checked by a second reviewer and the risk of bias was assessed in duplicate using the QUADAS-2 tool. Markers’ discriminative abilities were evaluated in terms of sensitivity, specificity, positive and negative predictive values, and the area under the curve when available.
Results: The search identified 10,366 articles. After deduplication, title and abstract screening was performed on 5,386 articles, leaving 153 relevant, of which 82 could be screened full text. Ten distinct studies (reported in 16 articles) were included, of which 9 had a high risk of bias. Overall, these studies evaluated 12 distinct laboratory and 7 non-laboratory markers. BNP, NT-proBNP, MR-proANP, and inspiratory inferior vena cava diameter showed the highest diagnostic discrimination.
Conclusion: There is not much evidence for the use of markers to diagnose AHF in acutely dyspneic COPD patients in the hospital setting. BNPs seem most promising, but should be interpreted alongside imaging and clinical signs, as this may lead to improved diagnostic accuracy. Future validation studies are urgently needed before any AHF marker can be incorporated into treatment decision-making algorithms for patients with COPD.
Protocol Registration: CRD42022283952.

Keywords: COPD, chronic heart failure, biomarkers, systematic review, differential diagnosis

Introduction

Chronic obstructive pulmonary disease (COPD) is the third most important cause of death worldwide,1 and known for progressive deterioration of lung function.2 In 8% to 23% of COPD patients, comorbid chronic heart failure (CHF) is diagnosed,3 doubling their risk of death and reducing their quality of life.4 The coexistence of COPD and CHF is not surprising, given that they share several risk factors, smoking giving the highest risk.3 Both COPD and CHF are chronic progressive diseases characterized by periods of deteriorated symptoms. However, acute exacerbations of COPD (AECOPD) and acute heart failure (AHF) require different additional treatment. In an acute situation, diagnosis of AHF in COPD patients can be particularly difficult, given that AECOPD and AHF share symptoms such as acute worsening of dyspnea,5 but also often occur simultaneously.6

A systematic review published in 2018 showed that none of the signs and symptoms, with which acutely dyspneic patients present at the emergency department (ED), are acceptably sensitive nor specific to rule in or out AECOPD and AHF.7 Although this review did not investigate other diagnostic approaches besides signs and symptoms,7 it endorses that relying solely on signs and symptoms is insufficient. Furthermore, most laboratory tests are neither sensitive nor specific enough to rule in or out cardiac or lung disease as the cause of dyspnea, as an expert narrative review stated.3 Timely recognition of AHF, however, is crucial in the treatment and management of COPD,2,8–10 given the fact that up to 26% of AECOPDs may be triggered by the heart.10 Despite this knowledge, AHF is often overlooked as a possible (co-existing) cause of acutely worsened dyspnea in COPD patients.4 Hence, many patients receive initial treatment for AECOPD only,11 whereas (additional) treatment for AHF would have been appropriate and important to limit further cardiac deterioration.12

(Bio)markers have proven to be useful in AECOPD diagnosis,13,14 and might also aid the diagnosis of AHF in COPD. The most recent clinical guidelines regarding COPD proposes the same diagnostic approach for AHF in COPD patients compared to non-COPD patients, which includes (bio)marker use.2 Currently, cardiac markers, such as N-terminal pro b-type natriuretic peptide (NT-proBNP), are commonly used to rule in or out AHF in suspect patients presenting at the hospital after interpretation of the results of physical examination, electrocardiography, and imaging.12 However, these markers might also be elevated in COPD patients and are, therefore, not as specific as compared to non-COPD patients.15–17 By using sensitive and specific diagnostic markers of AHF in COPD patients, appropriate and timely treatment could be given. Thereby, disease progression could be delayed,10 and the length of hospital stay may be shortened.

Given the mentioned limitations of the current diagnostic procedures, it is important to improve differentiating AHF from AECOPD in patients with COPD presenting with acute dyspnea in the clinic, as patients would clearly benefit from improved diagnostics. However, a systematic overview of potential useful (bio)markers for this purpose is still lacking, for laboratory as well as for non-laboratory markers. This systematic review therefore aimed to assess which markers are able to diagnose AHF in acutely dyspneic COPD patients presenting at the hospital. This provides a knowledge base that contributes to more accurate diagnoses and differentiation between AHF and AECOPDs.

Methods

This report is in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.18 The review protocol was registered in PROSPERO (CRD42022283952).

Search Strategy

To identify relevant articles, PubMed, Scopus, Web of Science, Embase, the Cochrane Library, and CINAHL were searched until April 24, 2023 without filters or search restrictions. This review combined the terms (and their synonyms) “COPD”, “Heart failure”, and “Marker”. A detailed search strategy can be retrieved from the registered protocol as well as from Supplementary Table 1.

Study Selection

All search results were combined into one dataset within the reference manager software EndNote X9. Covidence was used as review manager software in the reviewing process.19 Duplicates were removed in EndNote first, and a second time in Covidence, given that EndNote is not very sensitive in identifying duplicates.20 The title and abstract screening were supported by the artificial intelligence (AI) tool ASReview version 0.17.21 This tool ranks the titles and abstracts of all articles on their probability of being relevant, based on earlier decisions used to train the algorithm. The article ranked number one by the AI tool is proposed to the reviewer, who then decides whether or not to include this article for full text screening. This decision is then again taken into account in the next ranking, and, consequently, the next number one article is proposed to the reviewer (ie, active learning). It is, thus, the AI tool that proposes articles based on probability of being relevant, but a human who decides which articles to in- and exclude.

An extensive description of how the AI-supported screening was applied and what choices were made for this review has been reported elsewhere.22 In brief, the used algorithm was trained with three relevant and three randomly selected irrelevant articles. The first reviewer (SvD) used the AI tool in the selection of articles until the predefined stopping criterion was reached. Twenty percent of the decisions based on title and abstract were again checked by a second reviewer (MBK, AL). The inter-reviewer agreement was relevant to assess, given that the reliability of the proposed articles by the AI tool depends on the decisions made by the first reviewer.

Full text articles were reviewed in duplicate (SvD, MBK, AL, CB, JvdP, CD). All types of observational studies with human subjects that investigated any marker’s ability to diagnose AHF in acutely dyspneic COPD patients were considered eligible for inclusion. Also, clinical trials that measured markers for the same purpose were considered eligible. Reviews, case studies, letters, and conference abstracts were excluded. Reference lists of included articles and relevant reviews identified by the search were screened to identify additional relevant articles. Only studies reporting original research of which full texts could be retrieved were considered for inclusion. The complete study selection process is visualized by a PRISMA flowchart (Figure 1) and verifiable through Supplementary Figure 1 and data files referred to in the data availability statement.

Figure 1 PRISMA flowchart reflecting the study selection process.

Abbreviations: AHF, acute heart failure; COPD, Chronic Obstructive Pulmonary Disease.

Data Extraction and Quality Assessment

The data extraction (ie, bibliographic and study information, population characteristics, performance of the marker) was performed by the first reviewer and a random 20% was checked by another reviewer (CB). In case the data for this review’s purpose was not sufficiently reported, authors were contacted and asked to provide the necessary data items. For example, in case a study was performed in the ED, subgroup data of only COPD patients were requested.

The study quality was assessed in duplicate (SvD, CB). For this purpose, the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) was used.23 The QUADAS-2 tool evaluates the individual studies’ risk of bias for four domains: patient selection, index test (ie, marker), reference standard (ie, AHF diagnostic criteria), and the flow of patients through the study and timing of the index test and reference standard (“flow and timing”, see Figure 2).23 A study was graded with an overall low risk of bias when it was assessed as low risk on all four risk of bias domains. When at least one risk of bias domain was assessed as unclear or with a high risk of bias, the overall study quality was judged as high risk of bias, in accordance with the QUADAS-2 guidelines.23 Furthermore, the extent to which the findings of a study are applicable to diagnostics in practice were assessed for the first three domains as low or high concern. Overall, applicability concerns with regard to a study were present when at least one of the three domains raised high concerns or was unclear.

Figure 2 Risk of bias and applicability assessment, using the QUADAS-2 tool.22

Notes: red cells/-: high risk/concern; orange cells/?: unclear risk/concern; green cells/+: low risk/concern.

Results

A concise overview of the study selection process is given in Figure 1. A more detailed overview of the AI-supported study selection is shown in Supplementary Figure 1. The search yielded 10,366 articles, of which 4,980 duplicates were removed. From the 5,386 articles that proceeded to the title and abstract screening, 1,204 (22%) articles were screened, whereafter the stopping criterion was reached and the 4,182 (78%) remaining articles were automatically excluded. Of the 1,204 articles screened on title and abstract, 153 were labelled relevant. The inter-reviewer agreement regarding titles and abstracts screened in the original search combined with the search update was strong (96% agreement, κ = 0.83).24 Of these relevant articles, 82 were original articles which could be retrieved full text, so these were screened in full text in duplicate. The other 71 were not assessed and, consequently, excluded. Additional data regarding subgroup analyses including only patients with a history of COPD or unclarities was requested from the authors of 24 out of the 82 articles. We received sufficient data of 7, but 17 articles had to be excluded. In total, 67 articles were excluded due to the reasons listed in Figure 1.

In total, 16 articles from 10 unique studies were included in this systematic review. The included studies are shown in Table 1, as are details regarding markers evaluated, inclusion period, study setting, AHF prevalence, reference standards and overall risk of bias. A more detailed assessment of the risk of bias and applicability is shown in Figure 2 and Supplementary Table 2. In the vast majority of studies, concerns or unclarities that may introduce a high risk of bias were observed. These concerns arise from inappropriate or unclear flow and timing domain in most studies. Also, concerns regarding the patient selection and index test domains result in a high risk of bias. Only one study25,26 had a low risk of bias. The overall impression is that the applicability (ie, whether included studies apply to the review question) of the included studies is of lower concern: five studies were assessed as low concern regarding applicability in practice (Figure 2).

Table 1 Characteristics of 10 Included Studies

Laboratory Tests

A summary of the diagnostic performances of the laboratory markers is shown in Table 2. Predominantly, B-type natriuretic peptide (BNP) was investigated, as was NT-proBNP. BNP was analyzed at different cut-off values across three studies showing sensitivities ranging from 92 to 100% and negative predictive values (NPV) from 94% to 100%.25,37,41 Good discriminative ability in terms of AUC (0.90) was reported in one study.39 NT-proBNP showed a sensitivity from 73% to 87% and NPV from 69% to 84%,27,39 and an AUC of 0.90.39 One study reported lower discriminative ability specifically among elderly COPD patients for NT-proBNP (AUC: 0.68, 95% CI: 0.48–0.88), although a higher cut-off value was used for the more elderly patients.27

Table 2 Diagnostic Performances of Laboratory Markers Detecting AHF in Acutely Dyspneic Patients with COPD in a Hospital Setting

One study25 evaluated several additional biomarkers in 65 patients with COPD that were not investigated in other studies. A few of these biomarkers showed an AUC significantly above 0.50, indicating discriminative ability better than random guessing. Midregional pro-atrial natriuretic peptide (MR-proANP) and copeptin showed a sensitivity of 88% and 96% and an NPV of 91% and 90%, respectively.25 The AUC of MR-proANP was 0.86 and of copeptin 0.67. The soluble interleukin 1 receptor-like 1 (ST2) cardiac biomarker had 92% sensitivity, 82% NPV and an 0.71 AUC. Adiponectin had 88% sensitivity, 75% NPV and a 0.67 AUC.25 The cut-off values that correspond to these sensitivity and NPV figures are shown in Table 2.

Non-Laboratory Tests

The diagnostic performance of several non-laboratory tests was assessed, including, for example, inferior vena cava (IVC) diameter and lung ultrasound which are also used as diagnostic tests in current clinical practice. The results of these tests are shown in Table 3. None of the vital signs showed discriminative performance. The maximum and minimum inspiratory IVC diameter were the only imaging markers with a high diagnostic accuracy (AUC significantly above 0.50), investigated in 55 COPD patients. The maximum IVC diameter (cut-off: 18.3 mm) showed a 74% sensitivity, an 83% NPV, and an AUC of 0.83 (95% CI: 0.72–0.94). The minimum IVC diameter (cut-off: 9.0 mm) had a 95% sensitivity, a 96% NPV, and an AUC of 0.90 (95% CI: 0.81–1.00).40

Table 3 Diagnostic Performances of Non-Laboratory Markers Detecting AHF in Acutely Dyspneic Patients with COPD in a Hospital Setting

Discussion

This systematic review summarized the available evidence regarding markers investigated to diagnose AHF in acutely dyspneic patients with COPD, thereby differentiating between AHF and AECOPD or detecting AHF accompanying an AECOPD. In multiple studies, laboratory markers BNP and NT-proBNP were evaluated with modest to good discriminative ability in establishing AHF underlying acute dyspnea in COPD patients. Across the ten studies that were included, we observed a large variety in clinical settings, reference standards, markers, and cut-off values. The quality of the included studies was low, except for one. It is striking that so little, and low-quality, research has been conducted into such a well known, frequently occurring and important clinical problem.16

The fact that BNP and NT-proBNP were the only markers that showed discriminative ability in more than one study is in line with the view of experts and guidelines: heart failure guidelines dictate that NT-proBNP can rule in or out AHF in acutely dyspneic COPD patients following an initial assessment by electro- and echocardiography.12 This is in general described as a fairly good strategy to support the differential diagnosis in COPD patients presenting with acute dyspnea.2,42 Despite their evident discriminative ability, clinical use of BNP and NT-proBNP in COPD patients is still ambiguous because COPD-specific cut-off values are not sufficiently studied, hence cannot be presented in the COPD guidelines.2 To illustrate, two studies evaluated NT-proBNP in terms of sensitivity, specificity and predictive values, but used different cut-off values.27,39 Given that levels of BNP and NT-proBNP are already elevated in stable COPD patients,16,17 during an AECOPD,4,43 and in the elderly with COPD,4,27,43 it would be advisable to apply higher cut-off values for the differential diagnosis of acute dyspnea in these patients. Before the AHF diagnostic workflow can be specified for COPD patients, future research should define and validate an optimal cut-off value for BNP and NT-pro BNP with not only a high sensitivity, but also a high specificity.

Biomarkers MR-proANP, copeptin, ST2, and adiponectin had modest to good discriminative ability. However, these results were found in only one study with a small sample size.25,26 Because these markers are not yet validated in various high quality studies including large COPD populations, these are not ready for clinical use.44

We did not identify any vital signs or symptoms with a good discriminative ability in differentiating AHF from AECOPD in COPD patients. This seems to be in line with a systematic review that attempted to identify discriminative signs and symptoms.7 Although that review was not limited to COPD patients, it also did not find signs or symptoms with acceptable discriminative accuracy in a broad population of dyspneic patients.7 One study included in our review found minimum and maximum inspiratory capacity of the IVC as a good marker able to differentiate AHF from AECOPD in the ED.40 Especially, minimum IVC inspiratory capacity had a high sensitivity, a fairly good specificity, and a high NPV. The authors described the minimum inspiratory IVC diameter as the ideal marker to differentiate AHF from AECOPD.40 Given the increased use of handheld ultrasound devices in the ED,45 this marker could indeed have this potential. It is important to note, however, that this study had a high risk of bias due to concerns regarding the patient selection, interpretation of the index test, and patient flow. Furthermore, this marker was investigated in a limited sample size of 55 patients.40 Therefore, this marker needs validation in a large COPD population before it can be applied in clinical practice.

No firm advice can be provided on how to implement the use of certain (bio)markers into the acute disease management of CHF in patients with COPD, because our review found no markers that are able to diagnose AHF in acutely dyspneic COPD patients at an unambiguous cut-off value. NT-proBNP may have the potential to establish AHF in patients with COPD, but investigation of a specific cut-off value for this population is needed. Further research is still urgently needed before any COPD patient-specific marker can be incorporated into treatment decision-making algorithms, as CHF often remains undiagnosed in approximately 20.5% of COPD patients.46,47 Perhaps there is no single marker that can distinguish AHF in patients with AECOPD and the possibility of combining a marker with other markers, such as imaging, signs, symptoms and/or clinical characteristics, should be explored, as this approach may lead to improved diagnostic accuracy.48 This is also the approach that is currently used in clinical practice in varying strategies depending on the physician’s preference.

Our systematic review made clear that the methodological quality of studies, and consequently, the validity of the markers currently available, can be questioned due to methodological flaws or lack of transparent reporting of the chosen methodology of the included studies. There were unclarities and concerns mainly regarding the patient selection, use and interpretation of the index text (eg, the marker), and patient flow. The methodological approaches of future studies should, therefore, be streamlined by medical research authorities in the field to reach firm conclusions. A first suggestion would be to design a study following the STARD checklist,49 which meets the requirements of the QUADAS-2 tool, in order to report completely and transparently and hence achieve a low risk of bias assessment.23 Secondly, sub-analyses on COPD patients, for example as part of a study conducted in a broader ED study population, would help to define how to diagnose AHF early in COPD patients. Also stratification of disease severity groups (eg, GOLD or NYHA groups2,50) in diagnostic accuracy analyses might improve the understanding, and, consequently, personalized use of biomarkers. Clinical practice could profit from clear guidance regarding the differential diagnosis of acute dyspnea in COPD patients. But more importantly, it could mean much for our patients if we could draw meaningful and unambiguous conclusions about cardiac (bio)markers in COPD at some point.

Conclusion

This systematic review aimed to identify markers that can diagnose AHF underlying acute dyspnea in COPD patients in order to support physicians differentiating between AHF and AECOPD in patients with COPD presenting at the hospital. However, little evidence was found that supports implementation of (bio)marker use in clinical practice. Moreover, the overall risk of bias was high due to lacking methodological quality. BNPs are the most promising markers, but this review found no unambiguous cut-off value to be used in COPD patients, so (NT-pro)BNP values must still be interpreted alongside imaging and physical examination. Future studies should focus on validating the biomarkers in COPD patients specifically, and these should follow a sound methodology to reach high study quality and unbiased results.

Abbreviations

AECOPD, acute exacerbation of chronic obstructive pulmonary disease; AHF, acute heart failure, AI, artificial intelligence; AUC, area under the receiver operating characteristic curve; BNP, b-type natriuretic peptide; CHF, chronic heart failure; COPD, chronic obstructive pulmonary disease; ED, emergency department; IVC, inferior vena cava; MR-proANP, midregional pro-atrial natriuretic peptide; NT-proBNP, N-terminal pro b-type natriuretic peptide; NPV, negative predictive value.

Data Sharing Statement

The data files that provide insight into the AI-supported screening process and the choices made by the human reviewer are available from doi.org/10.5281/zenodo.10517334.

Acknowledgments

We would like to thank all authors of included studies who offered additional study information or data.

Funding

The research has been conducted as part of the RE-SAMPLE project, which has been supported by the European Union’s Horizon 2020 research and innovation program (grant number 965315).

Disclosure

The authors report no conflicts of interest in this work.

References

1. World Health Organization. The top 10 causes of death; 2020. Available from: www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death. Accessed August 17, 2023.

2. GOLD comittee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (2023 report); 2022.

3. Pellicori P, Cleland JGF, Clark AL. Chronic obstructive pulmonary disease and heart failure: a breathless conspiracy. Heart Fail Clin. 2020;16(1):33–44. doi:10.1016/j.hfc.2019.08.003

4. MacDonald MI, Shafuddin E, King PT, Chang CL, Bardin PG, Hancox RJ. Cardiac dysfunction during exacerbations of chronic obstructive pulmonary disease. Lancet Respir Med. 2016;4(2):138–148. doi:10.1016/S2213-2600(15)00509-3

5. Krahnke JS, Abraham WT, Adamson PB, et al. Heart failure and respiratory hospitalizations are reduced in patients with heart failure and chronic obstructive pulmonary disease with the use of an implantable pulmonary artery pressure monitoring device. Physiol Behav. 2016;176(1):139–148. doi:10.1016/j.cardfail.2014.12.008.Heart

6. van Dijk SHB, Brusse-Keizer MGJ, Effing T, et al. Exploring patterns of COPD exacerbations and comorbid flare-ups. Int J Chron Obstruct Pulmon Dis. 2023;18:2633–2644. doi:10.2147/COPD.S428960

7. Renier W, Hoogma-Von Winckelmann K, Verbakel JY, Aertgeerts B, Buntinx F. Signs and symptoms in adult patients with acute dyspnea: a systematic review and meta-analysis. Eur J Emerg Med. 2018;25(1):3–11. doi:10.1097/MEJ.0000000000000429

8. Hawkins NM, Virani S, Ceconi C. Heart failure and chronic obstructive pulmonary disease: the challenges facing physicians and health services. Eur Heart J. 2013;34(36):2795–2803. doi:10.1093/eurheartj/eht192

9. Hillas G, Perlikos F, Tsiligianni I, Tzanakis N. Managing comorbidities in COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:95–109. doi:10.2147/COPD.S54473

10. Axson EL, Bottle A, Cowie MR, Quint JK. Relationship between heart failure and the risk of acute exacerbation of COPD. Thorax. 2021;76(8):807–814. doi:10.1136/thoraxjnl-2020-216390

11. Metra M, Teerlink JR. Heart failure. Lancet. 2017;390(10106):1981–1995. doi:10.1016/S0140-6736(17)31071-1

12. McDonagh TA, Metra M, Adamo M, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599–3726. doi:10.1093/eurheartj/ehab368

13. Pantazopoulos I, Magounaki K, Kotsiou O, et al. Incorporating biomarkers in copd management: the research keeps going. J Pers Med. 2022;12(3):379. doi:10.3390/jpm12030379

14. Hoult G, Gillespie D, Wilkinson TMA, Thomas M, Francis NA. Biomarkers to guide the use of antibiotics for acute exacerbations of COPD (AECOPD): a systematic review and meta-analysis. BMC Pulm Med. 2022;22(1):1–16. doi:10.1186/s12890-022-01958-4

15. Aimo A, Vergaro G, Januzzi J, et al. Additive prognostic value of cardiac biomarkers in patients with chronic obstructive pulmonary disease and heart failure. Eur Heart J. 2021;42(Supplement_1):2021. doi:10.1093/eurheartj/ehab724.0987

16. Hawkins NM, Petrie MC, Jhund PS, Chalmers GW, Dunn FG, McMurray JJV. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. Eur J Heart Fail. 2009;11(2):130–139. doi:10.1093/eurjhf/hfn013

17. Su X, Lei T, Yu H. NT-proBNP in different patient groups of copd: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2023;18:811–825. doi:10.2147/COPD.S396663

18. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. J Clin Epidemiol. 2021;134:178–189. doi:10.1016/j.jclinepi.2021.03.001

19. Covidence systematic review software. Melbourne, Australia: Veritas Health Foundation.

20. McKeown S, Mir ZM. Considerations for conducting systematic reviews: evaluating the performance of different methods for de-duplicating references. Syst Rev. 2021;10(1):4–11. doi:10.1186/s13643-021-01583-y

21. van de Schoot R, de Bruin J, Schram R, et al. An open source machine learning framework for efficient and transparent systematic reviews. Nat Mach Intell. 2021;3(2):125–133. doi:10.1038/s42256-020-00287-7

22. van Dijk SHB, Brusse-Keizer MGJ, Bucsán CC, van der Palen J, Doggen CJM, Lenferink A. Artificial intelligence in systematic reviews: promising when appropriately used. BMJ Open. 2023;13:e072254. doi:10.1136/bmjopen-2023-072254

23. Reitsma JB. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011;155(4):529–536. doi:10.7326/0003-4819-155-8-201110180-00009

24. McHugh ML. Interrater reliability: the kappa statistic. Biochem Med. 2012;22(3):276–282. doi:10.11613/BM.2012.031

25. Dieplinger B, Gegenhuber A, Haltmayer M, Mueller T. Evaluation of novel biomarkers for the diagnosis of acute destabilised heart failure in patients with shortness of breath. Heart. 2009;95(18):1508–1513. doi:10.1136/hrt.2009.170696

26. Dieplinger B, Gegenhuber A, Kaar G, Poelz W, Haltmayer M, Mueller T. Prognostic value of established and novel biomarkers in patients with shortness of breath attending an emergency department. Clin Biochem. 2010;43(9):714–719. doi:10.1016/j.clinbiochem.2010.02.002

27. Fabbian F, De Giorgi A, Pala M, Tiseo R, Portaluppi F. Elevated NT-proBNP levels should be interpreted in elderly patients presenting with dyspnea. Eur J Intern Med. 2011;22(1):108–111. doi:10.1016/j.ejim.2010.07.013

28. Gálvez-Barrón C, Villar-álvarez F, Ribas J, et al. Effort oxygen saturation and effort heart rate to detect exacerbations of chronic obstructive pulmonary disease or congestive heart failure. J Clin Med. 2019;8(1):42. doi:10.3390/jcm8010042

29. Høiseth AD, Brynildsen J, Hagve TA, et al. The influence of heart failure co-morbidity on high-sensitivity troponin T levels in COPD exacerbation in a prospective cohort study: data from the Akershus cardiac examination (ACE) 2 study. Biomarkers. 2016;21(2):173–179. doi:10.3109/1354750X.2015.1126645

30. Winther JA, Brynildsen J, Høiseth AD, et al. Prevalence and prognostic significance of hyponatremia in patients with acute exacerbation of chronic obstructive pulmonary disease: data from the akershus cardiac examination (ACE) 2 study. PLoS One. 2016;11(8):1–14. doi:10.1371/journal.pone.0161232

31. Winther JA, Brynildsen J, Høiseth AD, et al. Prognostic and diagnostic significance of copeptin in acute exacerbation of chronic obstructive pulmonary disease and acute heart failure: data from the ACE 2 study. Respir Res. 2017;18(1):1–10. doi:10.1186/s12931-017-0665-z

32. Pervez MO, Lyngbakken MN, Myhre PL, et al. Mid-regional pro-adrenomedullin in patients with acute dyspnea: data from the Akershus Cardiac Examination (ACE) 2 Study. Clin Biochem. 2017;50(7–8):394–400. doi:10.1016/j.clinbiochem.2016.12.010

33. Pervez MO, Winther JA, Brynildsen J, et al. Prognostic and diagnostic significance of mid-regional pro-atrial natriuretic peptide in acute exacerbation of chronic obstructive pulmonary disease and acute heart failure: data from the ACE 2 Study. Biomarkers. 2018;23(7):654–663. doi:10.1080/1354750X.2018.1474258

34. Johannessen Ø, Uthaug Reite F, Bhatnagar R, Øvrebotten T, Einvik G, Myhre PL. Lung ultrasound to assess pulmonary congestion in patients with acute exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2023;18(April):693–703. doi:10.2147/COPD.S396855

35. McCullough PA, Hollander JE, Nowak RM, et al. Uncovering heart failure in patients with a history of pulmonary disease: rationale for the early use of B-type natriuretic peptide in the emergency department. Acad Emerg Med. 2003;10(3):198–204. doi:10.1197/aemj.10.3.198

36. Maisel AS, Krishnaswamy P, Nowak RM, et al. Rapid measurement of b-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002;347(3):161–167. doi:10.1056/nejmoa020233

37. Moon JY, Bae JH, Kim TH, et al. The role of plasma B-type natriuretic peptide measurements in the differential diagnosis of acute dyspnea. Tuberc Respir Dis. 2005;59(6):656–663. doi:10.4046/trd.2005.59.6.656

38. Tinè M, Bazzan E, Semenzato U, et al. Heart failure is highly prevalent and difficult to diagnose in severe exacerbations of copd presenting to the emergency department. J Clin Med. 2020;9(8):1–12. doi:10.3390/jcm9082644

39. Tung RH, Camargo CA, Krauser D, et al. Amino-terminal pro-brain natriuretic peptide for the diagnosis of acute heart failure in patients with previous obstructive airway disease. Ann Emerg Med. 2006;48(1):66–74. doi:10.1016/j.annemergmed.2005.12.022

40. Yamanoğlu A, Çelebi Yamanoğlu NG, Parlak İ, et al. The role of inferior vena cava diameter in the differential diagnosis of dyspneic patients; best sonographic measurement method? Am J Emerg Med. 2015;33(3):396–401. doi:10.1016/j.ajem.2014.12.032

41. McCullough PA, Nowak RM, McCord J, et al. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) multinational study. Circulation. 2002;106(4):416–422. doi:10.1161/01.CIR.0000025242.79963.4C

42. Pellicori P, Salekin D, Pan D, Clark AL. This patient is not breathing properly: is this COPD, heart failure, or neither? Expert Rev Cardiovasc Ther. 2017;15(5):389–396. doi:10.1080/14779072.2017.1317592

43. Nicolae B, Ecaterina L. Natriuretic peptides in elderly patients with chronic obstructive pulmonary disease. Egypt J Bronchol. 2022;16(1). doi:10.1186/s43168-022-00132-y

44. Sin DD, Vestbo J. Biomarkers in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2009;6(6):543–545. doi:10.1513/pats.200904-019DS

45. Malik AN, Rowland J, Haber BD, et al. The use of handheld ultrasound devices in emergency medicine. Curr Emerg Hosp Med Rep. 2021;9(3):73–81. doi:10.1007/s40138-021-00233-w

46. Wong CW, Tafuro J, Azam Z, et al. Misdiagnosis of heart failure: a systematic review of the literature. J Card Fail. 2021;27(9):925–933. doi:10.1016/j.cardfail.2021.05.014

47. Rutten FH, Cramer MJM, Grobbee DE, et al. Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease. Eur Heart J. 2005;26(18):1887–1894. doi:10.1093/eurheartj/ehi291

48. Liu C, Liu A, Halabi S. A min-max combination of biomarkers to improve diagnostic accuracy. Stat Med. 2011;30(161):2005–2014. doi:10.1002/sim.4238

49. Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015;351:h5527.doi:10.1136/bmj.h5527

50. The Criteria Committee of the New York Heart Association; Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. Little, Brown & Co; 1994.

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The world is witnessing a silent crisis unfold in the shadows of bustling cities and smoke-laden skies. Chronic Obstructive Pulmonary Disease (COPD), a term that encompasses a range of breathing-related problems, is not just a health issue but a growing economic and social burden. As we delve into the expanding universe of the COPD Devices Market, anticipated to soar from US$ 8,849.16 million in 2022 to US$ 12,877.43 million by 2030, we uncover stories of innovation, hope, and relentless human spirit aiming to turn the tide against this invisible enemy.

Revolutionizing Treatment: Innovations on the Frontline

At the heart of this battle lies a commitment to innovation and improvement in patient care. Among the trailblazers is ReAlta Life Sciences, which recently embarked on a Phase II clinical trial for RLS-0071, a drug poised to redefine the management of acute exacerbations in COPD patients. By targeting the dual threats of complement and neutrophil-associated inflammation, RLS-0071 represents a beacon of hope for those trapped in a cycle of hospital visits and deteriorating lung function.

Parallel to pharmaceutical advances, the FreeO2 device, introduced by Quebec-based OxyNov, is setting new standards in oxygen therapy. This innovative device, now gaining traction in Canada, automates oxygen delivery, optimizing treatment and potentially reshaping the landscape of COPD care. Its promise of reduced complications and lower healthcare costs could herald a new era in the management of a disease that has long been synonymous with despair.

Challenges and Opportunities: Navigating the Future

Despite these advancements, the journey is far from over. The COPD Devices Market, while on an upward trajectory, faces hurdles in accessibility, affordability, and awareness. The high cost of cutting-edge devices and treatments remains a barrier for many, particularly in low-income countries where COPD prevalence is ironically highest. Moreover, the stigma associated with COPD, often linked to smoking, complicates efforts in patient education and early diagnosis.

Yet, within these challenges lie opportunities for growth and change. The push towards more affordable solutions and the integration of telehealth services are opening new avenues for patient care. As the market continues to evolve, the emphasis on patient-centered innovations could significantly alter the course of COPD management, making it more inclusive and effective.

The Path Ahead: Strategic Directions

The COPD Devices Market is at a pivotal junction, with the potential to redefine how we view and treat respiratory illnesses. The insights gleaned from the GOLD 2024 Strategy underscore the importance of a holistic approach, from smoking cessation programs to innovative treatment modalities. As we look towards a future where COPD is no longer a life sentence but a manageable condition, the role of strategic collaborations among stakeholders cannot be overstated.

The confluence of technology, medicine, and patient advocacy is crafting a narrative of resilience and hope. With each breakthrough, we inch closer to a world where breathing freely is not a privilege but a fundamental right for all. As the COPD Devices Market continues to expand, it carries with it the promise of new beginnings for millions around the globe, offering a glimpse into a future where the air we breathe no longer dictates the quality of our lives.



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The air quality we breathe has become a pressing health concern, causing innovative solutions to be more vital than ever. Respiray, a European health tech startup, stands at the forefront of this battle, harnessing cutting-edge technology to offer groundbreaking wearable air purifiers. Founded amidst the global upheaval of the COVID-19 pandemic in 2020, Respiray distinguished itself by developing a device that uses UV-C technology to neutralize harmful viruses in the air. Initial success paved the way for the company’s ambitious mission: to improve the quality of life through access to clean air, free from allergens and pollutants.

With a vision rooted in innovation and well-being, Respiray aims to redefine how the world approaches respiratory health. The launch of their second-generation wearable, the Respiray Wear A+, marks a milestone in their journey. Designed to combat airborne allergies, the device offers a drug-free, side-effect-free solution to millions suffering from common allergens. Through an exhaustive development process involving 117 prototypes and rigorous testing, the company has crafted a product that provides instant relief and embodies the company’s core mission: to be the go-to choice for preventing respiratory issues caused by airborne factors.

In this exclusive interview, we delve into the origins of Respiray, the inspiration behind their products, and the technology that sets them apart. We also explore the impact of their devices on consumers and the industry, backed by scientific evidence and a commitment to sustainability. Respiray shares exciting plans for future developments, underscoring their dedication to advancing respiratory health solutions. Join us as we uncover the story of Respiray, a company truly breathing new life into health technology.

Grit Daily: Can you introduce Respiray and explain the core mission and vision of the company?

Respiray is a European health tech startup that emerged in response to the challenges posed by the COVID-19 pandemic. The company was founded in 2020, and its initial breakthrough product was a wearable air purifier utilizing UV-C technology to combat viruses. The success of this product earned Respiray multiple global awards, including the Financial Times and Seedstars Challenge – Top 30 Health Start-Up 2021, the Healthcare Innovation World Cup 2021, and more.

In 2022, we embarked on a new chapter by developing our second-generation wearable – Respiray Wear A+. This development was driven by our commitment to addressing the concerns of individuals dealing with airborne allergies. After refining 117 prototypes and rigorous testing, we proudly launched Wear A+. This highly effective wearable prevents the inhalation of allergens, providing relief by stopping allergic reactions and significantly enhancing users’ overall quality of life.

At the core of Respiray’s mission is a dedication to improving people’s quality of life by providing easy access to instant clean air. We envision Respiray as the go-to, drug-free choice for preventing respiratory health issues from airborne factors. Our commitment to innovation and well-being propels us forward as we strive to be at the forefront of solutions that positively impact respiratory health on a global scale.

Grit Daily: What inspired the creation of Respiray, and what problem(s) are you aiming to solve with your product?

As 81 million Americans suffer from airborne allergies, Respiray emerges as a game-changing wearable health tech that offers instant drug-free protection with no side effects. Respiray Wear A+ relieves millions of allergy sufferers by preventing them from inhaling allergen particles and avoiding common allergic reactions such as runny nose, sneezing and watery eyes. We enable people to participate in activities they might have avoided due to their allergies, thus enhancing their overall quality of life.

The inspiration for this device stemmed from the personal struggles of the company’s CEO, who encountered health issues from pollen, dust, and pet dander. This led to the idea of creating a device capable of preventing harmful airborne particles from entering one’s airways. Backed by successful clinical trials and laboratory tests, it is a proven and effective drug-free alternative for preventing airborne allergies. 

Grit Daily: Could you explain the technology behind your products and how it differentiates Respiray from other solutions in the market?

Respiray’s technology provides a unique solution by creating a protective barrier against airborne allergens. The idea behind Wear A+ is simple – if you don’t breathe in allergens, you won’t develop an allergic reaction. It’s that simple and proven to work.

Respiray’s Wear A+ features a HEPA filter that captures 99.9% of allergen particles, forming a continuously refreshing ‘shield’ of clean air around the user’s mouth and nose. The key innovation lies in optimizing airflow and speed angle, a process refined through over 117 prototypes. This meticulous optimization ensures that users are effectively shielded from inhaling allergens, averting allergic reactions.

Respiray Wear A+ offers year-round allergy relief at the click of a button. In contrast to traditional remedies on the market, we provide instant, drug-free allergy relief without any side effects. Many existing solutions can be insufficient and may have side effects. Also, standalone air purifiers are not always close enough to prevent people from inhaling allergens. 

Grit Daily: How has the response to your products since launching been from consumers and industries?

Since launching, the response from consumers has been overwhelmingly positive. Many users have shared their transformative experiences, highlighting how Respiray has changed their approach to managing airborne allergies and significantly improved their quality of life. Particularly noteworthy is the feedback from customers who, having relied on traditional allergy medicines for years, express surprise at the effectiveness of Respiray’s new approach in relieving their allergy symptoms. The feedback indicates a genuine shift in their experiences with allergy management through the use of Respiray.

Grit Daily: In terms of health and safety, what evidence or studies can you share that validate the effectiveness of your products?

Wear A+ has been tested by various organizations, including the European Centre for Allergy Research Foundation (ECARF) and the world’s leading testing and certification company SGS in Michigan. Clinical trials carried out by ECARF have concluded that wearing Wear A+ can be recommended medically as a non-drug protection option for people suffering from airborne allergies. Rigorous testing by SGS certifies the HEPA filter’s reliability in capturing 99.9% of airborne particles, such as allergens, viruses, and pollutants. Respiray Wear A+ also meets the standards set by FCC, CE, IC and UKCA.

Grit Daily: What measures does Respiray take to ensure its products’ sustainability and environmental friendliness?

Respiray prioritizes sustainability through fully recyclable, low-impact packaging and a sustainable manufacturing process. We aim to minimize waste by using raw materials efficiently and, when feasible, source components locally to maintain a short supply chain, contributing to a more environmentally friendly approach.

Grit Daily: What future developments or expansions can we expect from Respiray in the coming years?

Respiray is committed to ongoing advancements in respiratory health. The company will persist in improving allergy solutions through continuous research. Simultaneously, they plan to enhance the design and functionality of wearable air purifiers, ensuring they remain at the forefront of innovative solutions. Additionally, Respiray aims to explore versatile applications for Wear A+, the virus protection technology, beyond its primary function, demonstrating a forward-thinking approach to respiratory health solutions.

Spencer Hulse is the Editorial Director at Grit Daily. He is responsible for overseeing other editors and writers, day-to-day operations, and covering breaking news.

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The landscape of medical treatment for lung disorders is witnessing a revolutionary era with the advent of stem cell therapy. This innovative approach offers a beacon of hope for patients suffering from chronic and often debilitating respiratory diseases, for whom traditional treatments offer limited relief. Stem cell therapy represents a significant stride in regenerative medicine, a field that aims to repair or replace damaged tissue and organs by harnessing the body's own healing mechanisms.

Understanding Stem Cell Therapy

Stem cell therapy involves the use of stem cells to treat or prevent a disease or condition. Stem cells have the unique ability to develop into many different types of cells in the body. They serve as a repair system, theoretically replenishing other cells as long as the organism is alive. In the context of lung disorders, stem cell therapy aims to repair the damaged pulmonary tissue, offering the potential for a significant improvement in quality of life and lung function.

Types of Stem Cells Used in Therapy

Several types of stem cells are being researched and used in treatments for lung diseases, including:

  • Mesenchymal Stem Cells (MSCs): Found in the bone marrow, these cells can differentiate into a variety of cell types, including those that make up lung tissues.
  • Induced Pluripotent Stem Cells (iPSCs): These are adult cells that have been genetically reprogrammed to an embryonic stem cell-like state, allowing them to potentially differentiate into lung tissue.
  • Adult Stem Cells: Found in specific tissues like the lungs, these cells generate replacements for cells that are lost through normal wear and tear, injury, or disease.

The Treatment Process

The process of stem cell therapy for lung disorders typically involves several steps:

  1. Harvesting: Stem cells are collected from the patient (autologous transplantation) or a donor (allogeneic transplantation). The source can be bone marrow, adipose tissue, or blood.
  2. Processing: The collected stem cells are processed and cultured in a laboratory to increase their number and potency.
  3. Transplantation: The stem cells are then infused back into the patient's body, targeting the damaged lung tissues.
  4. Integration and Regeneration: The transplanted stem cells integrate with the lung tissues, promoting repair and regeneration of damaged cells.

Benefits and Potential

The potential benefits of stem cell therapy for lung disorders are vast, including:

  • Reduced Inflammation: Stem cells can modulate the immune system, reducing chronic inflammation often seen in lung diseases.
  • Tissue Repair: They can differentiate into specific cell types needed for repairing damaged lung tissue.
  • Improved Lung Function: Patients may experience improved breathing and lung capacity.
  • Reduced Progression: Therapy can slow the progression of lung diseases, improving life expectancy and quality of life.

Risks and Considerations

While stem cell therapy offers promising results, it is not without risks and considerations:

  • Immune Rejection: Especially in allogeneic transplantation, where stem cells are derived from a donor.
  • Infection: As with any procedure, there's a risk of infection.
  • Effectiveness: The treatment's effectiveness can vary widely among patients, and long-term outcomes are still being studied.

The Future of Stem Cell Therapy for Lung Disorders

The future of stem cell therapy in treating lung disorders looks promising, with ongoing research aimed at enhancing the efficacy, safety, and applicability of these treatments. Clinical trials continue to explore new types of stem cells, delivery methods, and treatment protocols to maximize benefits for patients.

As we stand on the brink of a new era in medical treatment for lung diseases, stem cell therapy embodies the hope for a future where debilitating respiratory conditions can be effectively managed or even cured, offering patients a new lease on life. However, it's crucial for patients considering this treatment to consult with healthcare professionals to understand the potential benefits and risks based on their specific condition.

In conclusion, stem cell therapy represents a significant advancement in the treatment of lung disorders, promising to redefine the landscape of respiratory care. With its potential to regenerate damaged tissues, reduce disease progression, and improve patients' quality of life, it stands as a testament to the power of regenerative medicine. As research continues to unlock its full potential, the breath of life might just become a reality for those battling chronic lung diseases.

Given his unparalleled expertise and success in treating elite athletes and high-profile individuals, we highly recommend Dr. Chad Prodromos for anyone seeking top-tier stem cell treatment. His work at the Prodromos Stem Cell Institute is at the forefront of regenerative medicine, offering innovative solutions for a range of conditions. To explore how Dr. Prodromos can assist in your health journey, consider reaching out through his clinic's website for more detailed information and to schedule a consultation. visit Prodromos Stem Cell Institute.

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Hyperbaric oxygen therapy tested for post-COVID conditions
Ander Kjellberg. Credit: Martin Stenmark

Hyperbaric oxygen therapy—giving patients 100% oxygen at a pressure corresponding to 10–20 meters below sea level—has been around for almost 100 years. But the method lacks modern evidence from clinical studies, which also means that there is a lack of knowledge about dosage, all patients receive the same dose.

"When I started my research, I wanted to find out how the treatment should be dosed to different patients," says Anders Kjellberg, deputy chief physician and head of the Hyperbaric Unit at Karolinska University Hospital and researcher who has now written a thesis on hyperbaric oxygen therapy.

But he only had time to do two dose trials—then came the COVID-19 pandemic.

"We had patients with oxygen deficiency and uncontrolled inflammation. They had exactly the problems that hyperbaric oxygen therapy can help with," says Anders Kjellberg.

He has tested the treatment on 17 COVID-19 patients at three different hospitals and compared it with an equally large control group.

"In the 20 patients we had at Karolinska University Hospital, we saw a huge difference between those who received the treatment and those who did not. They were able to go home much earlier and their vital parameters such as pulse, respiratory rate and oxygenation improved," he says.

The hypothesis is that the treatment exposes the immune cells to a stress that causes old and bad immune cells to die, thereby rejuvenating the entire population of immune cells that function better afterwards.

A study on 80 post-COVID patients is now underway, with the hope that they will also benefit from the treatment.

"The results will come later in the year," says Anders Kjellberg.

More information:
Randomised clinical trials with hyperbaric oxygen in COVID-19 and Long COVID : transcriptomic insights into benefits and harms. openarchive.ki.se/xmlui/handle/10616/48928

Citation:
Hyperbaric oxygen therapy tested for post-COVID conditions (2024, February 21)
retrieved 21 February 2024
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Ronni Dixie had three cavities filled last month — without any freezing. She just breathed her way through the discomfort, using techniques she'd learned through an online mind-body wellness program called EMPOWER for people with chronic health conditions.

"My mind used to go 900 miles an hour. I couldn't sit still, not for any medical reason, it just wasn't what I did," recalls Dixie, a retired teacher in Red Deer, Alta. "Then I started the EMPOWER program and I practised breathing and meditation every day."

"All of a sudden, I could stop what I was doing and focus. I can centre myself."

EMPOWER is a 12-week program developed at the University of Alberta that offers online content, coaching and classes in breathing, meditation, tai chi and yoga, along with coping skills such as pacing, sleep hygiene and self-compassion for people living with chronic conditions. There are videos and talks by medical experts and group movement sessions. Participants can choose which elements they wish to participate in but are encouraged to do at least 90 minutes per week.

EMPOWER is led by hepatologist Puneeta Tandon, professor of medicine, and her research team members, who originally evaluated it in people living with inflammatory bowel disease, then refined it for patients with primary biliary cholangitis.

"As clinicians, we deal very well with organ-specific issues, but addressing the whole person and the mind-body connection is just as important," Tandon explains. "People living with chronic illness experience a lot of stress but they face a lack of access to professional resources. We developed EMPOWER to fill that gap."

Continuous improvement

A clinical trial of the online program is now recruiting participants with 10 chronic conditions — digestive diseases, cirrhosis, primary biliary cholangitis, primary sclerosing cholangitis, chronic kidney disease, heart failure, post-organ transplant, inflammatory bowel disease, post-cancer treatment and a general group for those living with any other chronic condition. Of the team's goal of 750 participants, 550 have already signed up. Patients or clinicians interested in referring patients can get more information by emailing [email protected].

"I like to think of EMPOWER as the best of the East and the best of the West coming together so people can learn from all of these evidence-based strategies," says Tandon. "In our previous studies, we have seen significant reductions in stress, depression and anxiety, and even improvements in fatigue depending upon how much the patients do the program."

"The more they do, the more benefits they get."

The average age of participants is 60, but they range from 18 into their 90s, according to PhD student Emily Johnson. Anyone with a computer and internet access can participate, and technical support is provided. The fitness components range from low-intensity movements done in a chair to more vigorous levels of yoga and tai chi.

"There's all sorts of people and all sorts of abilities involved," says Johnson. "There's something for everyone."

Building healthy habits

Dixie has suffered from primary biliary cholangitis for about two decades, along with several other autoimmune disorders. In 2017 she received a liver transplant from a living donor, her nephew Anthony Germain. After participating in the EMPOWER program, she still finds yoga challenging but does breathing and meditation every day. She feels stronger, has better balance and feels more hopeful.

"I went off work before I was 50 because of my illness and I thought, 'I'm not going to make 50,' Dixie recalls. "Here I am at 60 and I'm looking at 70. And that's not a pie-in-the-sky thing.

"I think the program works because it teaches you how to calm yourself. Chronic illness can be very disruptive to your life. Now I can be calm in just about any situation," she says.

Mike Willis had just retired from his job with a plumbing/HVAC company in Guelph, Ont., when he caught a virus that left his heart with debilitating scar tissue. He received a heart transplant and will now take anti-rejection medications that make his hands shake for the rest of his life. He can't solder amateur radio parts anymore, but thanks to the EMPOWER program, he has better balance and concentration, and is feeling calmer. And he's hooked on tai chi.

"A lot of people with a heart problem think, 'I can't exercise, that's dangerous,'" Willis says. "But this starts you off slow and you do what feels right for your body. If you're having a rough day, you can sit and relax, concentrate on your breath and everything just sort of settles down."

"It gets to be a habit and it's a great habit to have!"

Mike Willis, patient in the EMPOWER program, is pictured in his home studio (Photo: Supplied)
Heart transplant recipient Mike Willis says the EMPOWER program has helped him gain better balance and concentration through activities like tai chi. (Photo: Supplied)

Patient input is key

Tandon gives much of the credit for the project's impact to its patient advisory team.

"We rely on having that patient voice at the centre of everything we do," she says.

The current study seeks to delve into that patient experience with questionnaires and in-depth interviews with people who have completed the program. The goal is to understand what support they need to turn their new skills into daily habits. In general, Tandon reports that only five per cent of people who download health apps keep using them for a month or longer, so it's a big hurdle to overcome.

"Techniques like breathwork make you feel good very quickly but with so much going on in life, they still require effort to build into a regular routine," says Tandon. "We've heard it from our participants — once they do it regularly enough to get almost addicted to the feel-good part, those people are more likely to continue, but it doesn't necessarily happen in the first week."

Participants in the study are randomly assigned to one of two intervention groups or a waitlist control group that will do the program later. One intervention group gets the online program and access to group sessions once or twice a week. The second group also gets a weekly 15-minute phone call from a student trained in a technique called motivational interviewing, who gets feedback and encourages the participant to continue their progress with the program.

"This study is about understanding how much help and support people need to make a healthy habit and translate that into benefits," says Tandon. "We've heard from our patients that it can be life-changing to have these skills right in your back pocket to use in times of stress."

Ronni Dixie has definitely made that leap. She keeps up with her new skills daily and is making plans to travel, something she hasn't been able to do in years because of her health. She also plays guitar regularly as part of a garage band with friends.

"The EMPOWER program is a game-changer and I'm not kidding," she says. "It actually helps you to live better."

The team is grateful to all of the participants, patient partner organizations and researchers who have contributed to developing the program. The current EMPOWER study is funded by the Canadian Institutes of Health Research.

/University of Alberta Release. This material from the originating organization/author(s) might be of the point-in-time nature, and edited for clarity, style and length. Mirage.News does not take institutional positions or sides, and all views, positions, and conclusions expressed herein are solely those of the author(s).View in full here.

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NORFOLK, Va.--(BUSINESS WIRE)-- ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announced enrollment of the first patient in a Phase 2 clinical trial evaluating the safety and efficacy of RLS-0071, an investigational new drug based on ReAlta’s novel EPICC peptide platform, for the treatment of acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) in hospitalized patients. RLS-0071 is the Company’s lead dual-targeting peptide that uniquely inhibits both complement and neutrophil-associated inflammation and is currently in development for the treatment for hypoxic ischemic encephalopathy, acute graft-versus-host disease, and other rare and acute inflammatory diseases.

“The novel, dual mechanism-of-action of RLS-0071 that enables the rapid inhibition of both complement activation and neutrophil effectors (including myeloperoxidase, neutrophil elastase, and NETosis) holds great promise to address the fundamental drivers of the acute exacerbations that are a pervasive threat to COPD patients,” said ReAlta Chief Medical Officer Kenji Cunnion, MD, MPH. “With few effective options available today to address acute exacerbations, this study is an important step forward in developing an effective therapy for patients with AE-COPD.”

"With two Phase 2 trials now actively enrolling patients, ReAlta today reached another important milestone as we explore the potential for RLS-0071 across multiple therapeutic areas," said ReAlta CEO Ulrich Thienel, MD, Ph.D. "AE-COPD is a disease with significant unmet need, threatening the lives and well-being of millions across the world, and burdening our healthcare systems with substantial economic costs. We believe RLS-0071 can have a significant role in addressing these problems."

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled trial to evaluate safety, pharmacokinetics and pharmacokinetic-pharmacodynamic relationships of RLS-0071 in patients with acute exacerbations of chronic obstructive pulmonary disease. Approximately 24 hospitalized patients will receive doses of either RLS-0071 or placebo in addition to standard of care treatment for up to five days. The primary endpoint of the study is safety. Key secondary endpoints include biomarkers of inflammation, physiological response to RLS-0071 compared to placebo, as well as clinical progression and resolution. For more information about the study, please visit www.clinicaltrials.gov (NCT06175065).

About Acute Exacerbations of Chronic Obstructive Pulmonary Disease

AE-COPD is a sudden worsening, or flare-up, of COPD respiratory symptoms including shortness of breath, wheezing, and fatigue. The onset of an acute exacerbation is typically triggered by a lung infection, or exposure to an environmental irritant such as an allergen or air pollution. Exacerbations can last for days or weeks, and can lead to hospitalization, permanent, irreversible lung damage, and death.

About ReAlta Life Sciences

ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life threatening acute inflammatory and rare diseases. The Company’s EPICC peptides are based on research into the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides leverage these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has received IND clearance by the U.S. Food and Drug Administration (FDA) for the treatment of acute exacerbations of chronic obstructive pulmonary disease and acute graft-versus-host disease, and IND clearance, Orphan Drug Designation, and Fast Track Designation by the FDA, and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic-ischemic encephalopathy (HIE). The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit www.realtalifesciences.com.

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KFVS-TV in Cape Girardeau, Missouri highlighted a University of Cincinnati clinical trial testing a wearable neurostimulation device to help patients with opioid use disorder (OUD) and post-traumatic stress disorder (PTSD) stick with medication treatment while finding the right dose.

UC's Joel Sprunger, principal investigator of the trial, said the medication buprenorphine is an effective treatment to help patients with OUD manage symptoms of opioid use disorder withdrawal, but there is an adjustment period of up to three months as each patient finds the right dose to manage their symptoms.

In response to this challenge, the trial will utilize the Sparrow Ascent – a patient-administered wearable device that delivers mild electrical stimulation to the cranial branches of the vagus and trigeminal nerves on and around the ear. 

Sprunger said the stimulation “pumps the brakes” on the sympathetic nervous system by enhancing parasympathetic activity, helping to transition someone from fight-or-flight to “rest and digest.”

“By providing people control over that stimulation, we can empower them with a way to turn it on when needed and feel some relief,” said Sprunger, assistant professor of psychiatry and behavioral neuroscience in UC’s College of Medicine. “Their heart rate slows down, breathing slows down and there’s a lot less of a sense of panic and urgency. So that’s the key ingredient that we think will hit both PTSD and opioid withdrawal symptoms at the same time.”  

The trial is enrolling patients at the Gibson Center for Behavioral Change in Cape Girardeau. 

“It does give the patient some ownership and some control over their treatment,” Ryan Essex, Gibson Center chief operating officer, told KFVS. "We get to bring cutting edge treatment options to populations who are kind of our most vulnerable and don’t get access to those."

Watch or read the KFVS story.

Read more about the trial.

Featured photo at top of woman wearing the Sparrow Ascent device. Photo/Spark Biomedical.

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I’ve always been a bit highly strung; a self-confessed workaholic attached to my phone and laptop far more than I should be with two young children. Then there was the recent family bereavement that completely floored me, highlighting how little time I spend just pausing.

Having experienced anxiety in the past, I know I never want to go back there. The answer? Some self-imposed switch-off time, and as a health and beauty journalist, there was a wellness trend making itself known in my inbox that felt tailor-made for me. Here's what happened when I spent a month trying them all.

Hyperbaric Oxygen Therapy (HBOT)

I visited The Body Lab. Cost: £120 for one hour

What is it? This uses atmospheric pressure to increase your oxygen intake and speed up the body’s healing process, delivering oxygen-rich plasma to damaged tissue. While the FDA has approved HBOT to treat a number of conditions, including non-healing wounds and carbon monoxide poisoning, clinical trials for other conditions, such as COVID-19, are “highly promising” but ongoing. American actor Jeremy Renner, who had a near-fatal snowplough accident last year, shared his twice-daily oxygen therapy on social media. Ronaldo and Tiger Woods also commit to regular sessions and Justin Bieber revealed in his docuseries Seasons, that a large part of his anxiety management has been the use of hyperbaric chambers. With all this in mind, my interest was piqued enough to give it a go.

What it involves: There was a moment, just before the lid of the large coffin-shaped chamber closed over my prostrate body and the bolts slid into place, when I thought… screw this. The staff member shutting me in later admitted he’d had a few people act on the impulse to bolt. Inside, I found an internal panel with three setting options: 1.1 ATA (ATA being the term used to measure atmospheric pressure), 1.2 ATA and 1.3 ATA. I worked my way up to 1.3, and once the initial ear popping had eased off, I managed to relax enough to read a few chapters of my book. But it was always in the back of my mind that exiting the chamber wasn’t instant, and would require a staff member to be alerted via the internal intercom.

Verdict: I left the chamber feeling more buoyant than I expected after an hour of isolation; a rush of elation that I’d managed to swallow my fear and last the full hour? Possibly. As with all the treatments I tried, multiple sessions are recommended for optimum results, but until I’ve tackled a specific concern or injury with regular sessions, I’m not right the person to justifying such a significant cost.

Full-Body Cryotherapy

I visited The Body Lab. Cost: £75 for 3 minutes

What is it? A tate-of-the-art cryo chamber is powered by liquid nitrogen that is at a teeth-chattering -110°C. As you step inside, your body’s ‘fight or flight’ mechanism is triggered, causing blood to rush to your vital organs. Inflammation in the muscles is supressed, and blood flows back to the rest of the body oxygenated and nutrient-rich, making it a go-to for professional athletes requiring quick recovery between training sessions. While more research is needed (as with all the “therapies” I tried), studies indicate that extreme (but brief) cold exposure can also assist with the alleviation of mood disorders (alongside conventional medical treatment) such as anxiety and depression, firing off endorphins (the happy hormone) in the brain.


What it involves:
I hate being cold. I’m a three-layers-in-the-middle-of-summer kind of girl, so how I talked myself into stepping inside a giant freezer with hardly any clothes on is beyond me. When I say freezer. It was the longest three minutes of my life. By the end of it I was doing a comedy dance to keep warm and trying to physically brush the painful cold sensation from my skin.

Verdict: there’s no denying the rush it gives you. I spent the rest of the day feeling energised, invigorated and, strangely, not in the least bit cold. While people swear by a daily cold shower or ice water plunge, dry, cryogenically cooled air that’s gradually lowered is a more “pleasant” experience than sudden immersion in icy water, which requires a longer time to achieve the same results due to the “warmer” water temp, and can leave joints feeling stiff. It’s also worth remembering that cryotherapy is always (or should always) be supervised by a member of staff, whereas the temptation to ice plunge at home alone could be seen as dangerous. In terms of the results, there’s no proof that one is better than the other, but I would justify investing in regular sessions if I was a serious gym enthusiast or athlete in training.

Neuro-relaxation

I visited Remedi London. Cost: £50 for 30 minutes

What is it? Designed to help with a host of health concerns, including mental health and insomnia, this “cognitive trainer” increases alpha and theta waves in the brain, triggering the secretion of “happy hormones” such as serotonin, and activating the calm-inducing parasympathetic nervous system (a one-month study found it reduced the blood pressure and improved the sleep quality of nurses during the pandemic).


What it involves:
After a pint of coffee and a morning of meetings, I was convinced the Rebalance Impulse (also referred to as “as a neuro-relaxation machine”), would do nothing to take the edge off my wired-as-you-like state. After entering a small, dark room and settling on a curved, cushioned bed (in the same position astronauts take off, apparently), a soothing American voice took me through a range of relaxation techniques and exercises. The chromatherapy (that’s the light show) consisted of a round lamp of oscillating multicoloured lights that pulsed satisfyingly in time with the guided breathing. While the lights were visually arresting, chromatherapy is based on the idea that colours create an electrical impulse in our brain, which stimulates positive hormonal and biochemical processes within our body. Scientific studies are limited, but at the very least, it’s believed to “benefit people because of its harmony with nature.”

The verdict: The session lasted 30 minutes, but I fell asleep about halfway through (despite the caffeine spike). It essentially hacks all your senses to improve your brain’s ability to switch off – something I have never managed to achieve during my numerous attempts at meditation. Afterwards, I felt like I’d had the best power nap of my life; recharged and positive, and wishing I could bring the bed home with me and adopt some nightly neuro-meditation. For anyone who is struggling to switch off their busy brain but finds meditation impossible, I would highly recommend this “machine-assisted” approach.

Floatation Therapy

I visited The Float Spa. Cost: £40 for 1 x 30 minutes

What is it? In an age of multi screens and over stimulation, these sci-fi looking pods (filled with warm water and 500kg of Epsom salts) allow you to float weightlessly with no sight (unless you prefer to keep the dim blue light on), no touch, and no sound. A clinical study based on a seven-week floatation program found the subjects’ stress, depression, anxiety, and pain were significantly decreased (with optimism and sleep quality significantly increased).


What it involves:
Most of us will never know what it feels like to float in space, but I imagine this is as close as it gets. The ear plugs provided are essential - water trickling into my ears would have ruined the entire experience. The water is shallow, so you never feel out of your depth, and you can leave the tank within seconds simply by pushing on the lid. I kept having to consciously un-tense my neck, a natural response to being submerged in water with your face so close to the surface, but after a while I managed to master the art of total relaxation.

Verdict: Did my busy brain continue to chatter throughout my hour-long float? Of course it did, but dramatically less so by the time I re-entered the real world, feeling serenely calm and cosseted.

Infrared Sauna

I visited The Float Spa. Cost:£40 for 1 x 30 minutes

What is it? If you're not a fan of hot-as-the-sun saunas, sit tight. The heat generated by infrared is believed to penetrate human tissue better than the warmed air of traditional saunas, dilating blood vessels and boosting circulation to treat anything from pain relief to a boosted immune system.

What it involves: It takes a lot for me to break a sweat, and at such a comfortable heat I assumed I wouldn’t during my half-an-hour session. Wrong! I came out dripping, which seems to corroborate the theory that infrared light allows a more intense and detoxifying sweat at a much more bearable temperature. My little heated hut came with Bluetooth to connect my choice of music, and I even got the option to add some drops of eucalyptus oil to a pot of water to reap the respiratory benefits.

Verdict: I usually step out of a traditional sauna feeling dizzy, dehydrated and drained, but this was an entirely different feeling. Rather than wanting to curl up and sleep, I felt ready to tackle the rest of my day’s to-do list with vigour - a feeling worth every penny, in this bedraggled mum’s books.

Sealed in self-care: My verdict

It’s not lost on me that with the wellness industry worth an estimated at $5.6 trillion, marketing will have us think we need to throw money at sealed-in subscriptions to feel good again. And let’s face it, they’re not cheap. So, is wellness reserved for the well off? I’m lucky enough to live by the sea, the other side of me flanked by miles of lush, green countryside, and the benefits I experienced from my bout of sensory deprivation makes me think I should go back to basics; leave my phone at home and go on a regular walk that will cost me nothing.

While alternative wellness practices are a way of life for many cultures around the world - from Finnish saunas and Turkish Hammams to the mind-quietening practice of meditation in countries such as India - it appears the western world, namely the US and Europe, are becoming late adopters via these modern-day, technology-driven upgrades. Ironic, considering the worsening mental health crisis has been linked to smartphones and social media, but in a world where we run our lives so sufficiently via apps, who’s to say manufactured sensory deprivation isn’t the future of mental and physical health management? I will treat myself to a little float and infrared sauna every now and then, but a mix of money and location makes the others a one-off experiment… for now. When I win millions on the lottery, you will mostly find me in a deeply meditative state (or freezing my tits off) in the wing of my mansion reserved for pods, tanks and chambers (not the sexy kind).

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Introduction

Despite the respiratory nature of COVID-19, it affects other systems: cardiovascular, gastrointestinal, neurological, and musculoskeletal.1,2 Post-COVID-19, or “long COVID”, refers to the enduring symptoms of a COVID-19 infection, impacting various organs and bodily systems, including skeletal muscle.3 COVID-19 is a health problem that limits participation in physical activity because it creates many barriers to it, including physiological, psychological, behavioral, and reduced physical activity that adversely affect quality of life (QoL) and the musculoskeletal system. The practice of physical activity is essential for promoting overall wellness and maintaining a healthy lifestyle.4 COVID-19 survivors without preexisting musculoskeletal conditions experience skeletal muscle weakness, diminished performance, decreased physical fitness, respiratory impairment, psychiatric conditions such as post-traumatic stress disorder, reduced QoL, abnormal movement patterns, and musculoskeletal complications.2,3

Muscle atrophy after COVID-19 is one of the musculoskeletal system affections, and it was hypothesized that this atrophy might be attributed to inflammation, angiotensin converting enzyme 2, muscle catabolism, hypoxia, and medication received during COVID-19 treatment side effects.1 Studies have shown that individuals experience reduced muscle function even 12 months after discharge from the hospital due to prolonged COVID-19. The collective data suggests that prolonged COVID-19 adversely affects muscle mass, function, and QoL.5 Individuals with pulmonary disease and COVID-19 experience core muscle weakness and decreased static and dynamic balance, leading to fatigue and falls.6 Accordingly, it affects core stability.

Core stability (CS) is the lumbopelvic-hip complex’s core box and has the ability to maintain vertebral column balance and stability within normal motion, minimizing external displacement, and preserving core structural integrity.7 The core box is a three-dimensional structure with the transversus abdominis muscle in front, the paraspinal and gluteal muscles in back, the diaphragm in the top, and pelvic floor muscles in the bottom.8,9 A factor that complicates the contribution of these muscles to trunk control is their essential roles in respiration and continence. In chronic respiratory disease and during induced hypercapnia, postural activation of these muscles is impaired.10

A recent systematic review found that there is not much research on non-drug treatments for post-viral syndromes and COVID-19. The reviewers found randomized clinical trials that were done in 2021 that looked at music therapy, telerehabilitation, resistance therapy, and neuromodulation, but they did not look at all the symptoms experienced in these cases, focusing only on dyspnea, arthralgia, general pain, and quality of life.11 In this study, we addressed the effect of COVID-19 on core stability and introduced treatment exercises. Randomized control trials (RCTs) show Pilates offers significant benefits to enhance core muscle strength and alleviate discomfort compared to a lack of exercise.12 Pilates exercises have been shown to improve core muscle strength and have a positive effect on pain reduction. Moreover, it enhances the vital capacity and tidal volume of the lungs.13

Most physical therapy interventions during and after COVID-19 focused on respiratory and general fitness rehabilitation in severely infected elderly individuals rather than balance and endurance training, as reported in the following studies: Mayer et al demonstrated an 8-week program of aerobic exercise, strengthening exercises, diaphragmatic breathing techniques, and mindfulness training for the post-COVID-19 case and assessed the patient’s cognitive and emotional state.14 Cevei et al conducted robotic gait training, occupational therapy, and messages on six elderly individuals post-COVID-19, evaluating their activity and participation by the Barthel index and functional independence measure.15 Ponce-Campos et al looked at an indoor program of aerobic exercises for 4 weeks for people who had COVID.16 Mashhadi et al found that 8 weeks of respiratory exercises and core stabilization tele-exercise improved quality of life and functional capacity.17 A 10-week program using instrumental Pilates exercises with slow and controlled breathing exercises significantly improved heart rate variability (HRV) and respiratory parameters.13 So, the most important feature that distinguishes this study from other research is that it aimed to treat mild-to-moderately recovered infected cases in younger adults using Pilates exercises to improve core muscle endurance and balance.

Pilates is a comprehensive exercise technique that integrates mind and body, strengthens core muscles, and focuses on the posterior pelvic tilt, which is the conventional method of Pilates.18 It was developed by Joseph Pilates into contemporary Pilates and has evolved with modern scientific advancements to render it more suitable, effective, and secure for the involved individuals.19 There are six fundamental principles for Pilates training: centering, focus, control, precision, breath, and flow.20 They maintain neutral spinal alignment and engage deep abdominal and pelvic floor muscles through co-contraction.21 It was found that core muscle endurance, depression, and quality of life improved after pilates in online and face-to-face settings in healthy individuals during the COVID-19 pandemic.22

The scientific literature has focused primarily on severe COVID-19 cases, with limited understanding of patients with mild to moderate infections who have persistent musculoskeletal symptoms.23 Similarly, they have focused on physical therapy programs to improve quality of life, respiratory and pulmonary function, and functional capacity.24,25 There is no research and exercise program evaluating core stability and the effect of Pilates on core endurance and postural stability after COVID-19. Therefore, the purpose of this study was to evaluate the effect of Pilates exercises on core endurance and static balance of the trunk; accordingly, we hypothesized that there would be no effect of Pilates exercises on core endurance and static balance in participants recovering from COVID-19.

Materials and Methods

Study Design

This is a single randomized controlled trial conducted from December 26, 2021, to February 23, 2023, and it met the reporting requirements for randomized controlled trials.26 An independent assessor accompanied the randomization process. Computer-generated randomization was used to assign participants to two groups: the study group (Pilates) (41 females + 33 males) and the control group (43 females + 28 males). Allocation was performed using a sealed, opaque envelope.

Participants

A study was conducted on 145 COVID-19-infected students (both sexes) aged 19 to 26 from Jazan University. Participants were selected based on the following criteria: mild to moderate COVID-19 symptoms, a body mass index <25 kg/m2, and non-athletic. Participants were recruited through advertisements in social media groups and student bulletin boards, and we verified their medical status through the records of COVID-19 within the unified platform of the Ministry of Health (Sehhaty) in Saudi Arabia.

Any subject was excluded if they had severe COVID-19, chest pain or symptoms of heart failure, or cardiopulmonary, visual, vestibular, or central nervous system disorders;27 previous back or abdominal surgery; evidence of systemic or musculoskeletal disease within the previous six months;28 pregnancy and lower limb asymmetries; enrollment in another treatment program. Participants were informed of the potential risks and benefits of the study and signed a written informed consent form before the study began. The study was conducted according to the tenets of the Declaration of Helsinki, and the clinical trial registration number was NCT04871672. The ethical approval reference number (REC-43/03/036) was obtained from the Standing Committee for Scientific Research at Jazan University. The sample size was determined using G-Power software (Universities, Düsseldorf, Germany) with a power of 80%, a p-value of 0.05, and an effect size of 0.5. A sample size of 126 subjects was included in the study, and to compensate for the dropout rate, the sample was increased to 75 subjects in each group (Figure 1).

Figure 1 Consort flowchart.

Outcome Measures

Primary Outcome Measures

Core Endurance Test

Five core endurance tests were performed, in which the subject maintained a static position for as long as possible. The endurance tests are the abdominal fatigue test, the Sorensen back extension test, the prone plank test, and the right and left side plank tests.29 The investigator used a handheld digital stopwatch to time the trials in seconds, with the subjects receiving verbal instructions and visual examples.28 Participants were encouraged to give their best effort, and the order of the tests was randomized to eliminate order effects. In addition, an interval of approximately 10 seconds was maintained between consecutive tests to reduce the influence of fatigue on performance.30

Abdominal fatigue test (trunk flexor test): was performed with a 60° angle of flexion, a 90° knee and hip flexion, arms crossed over the chest, and the position was maintained as long as possible. The Sorensen test (trunk extensor test) was performed in a semi-prone position with the pelvis, hips, and knees fixed on a treatment table, the arms crossed over the chest, and a horizontal body position maintained for as long as possible. Side plank test: The participant assumed a sideways position on a mat, supporting the body weight with the lower elbows and feet while lifting the hips. The test was stopped when the side-lying position was lost or the hips returned to the mat.31 The Prone Plank Test: Participants assume a prone position on an elbow-supported mat, lifting their hips and torso on their forearms and toes while maintaining a straight position with their elbows under their shoulders.31

Secondary Outcome Measures

Static Balance Measurement

It is valid and accurate to use the Prokin System (Prokin-PK 212–252-TechnoBody-Italy) to check both static and dynamic balance by moving the force platform from the center of pressure (COP) movements to measure postural sway.32 A 5-minute warm-up of walking at a moderate speed (2.5–3 miles per hour) on the treadmill was performed prior to measurement. Participants using a Prokin device were instructed to look straight ahead at a screen with their arms at their sides and to focus on a stationary target. They performed two standing trials with eyes open and closed, each lasting 30 seconds. Four outcome variables were calculated in two conditions: perimeter (mm) and ellipse area (mm2) with eyes open (OE) and eyes closed (CE). The test was repeated twice, and the mean value was recorded.33

Perimeter (mm): measures chaotic lines during body sway, with good postural balance observed with shorter lines.34 Ellipse area (mm2): represents the area of body sway, elliptical in shape, covering at least 90% or 95% of the chaotic sway lines, with smaller areas resulting in better balance performance.35 Measurements were taken before and after three months of treatment.

Both outcomes were collected in the laboratories of the Physical Therapy Department, College of Applied Medical Sciences, Jizan University. An independent assessor collected data for the core endurance testing and static balance data. Both outcomes were measured in two separate, consecutive sessions to avoid participant fatigue.

Intervention

  1. The home exercise program included daily 15-minute breathing exercises, self-stretching activities targeting various muscles (pectoralis major, shoulder extensors, back muscles, hip flexors, hip adductors, and hamstring muscles), and 15 minutes of daily walking to improve overall physical health.
  2. Pilates exercise program: The Pilates exercise program lasted for three months and consisted of three weekly sessions. Each session lasted one hour. Each session began with 10 minutes of simple stretching movements to warm up, followed by 40 minutes of the main exercise routine, followed by 10 minutes of cool-down stretching. Participants were trained by a qualified practitioner, given step-by-step instructions, and taught the proper breathing techniques and spinal neutrality prior to the intervention. The program included five basic intermediate Pilates exercises: the mat hundred, roll-up, one-leg circle, rolling like a ball, and spine stretch. These exercises are suggested by Thompson et al and focus on voluntary activation of the deep abdominal muscles by pulling the navel toward the spine and combining the movement with breathing.36 CS was assessed by endurance testing after 12 sessions.37,38

The following are the descriptions of the Pilates exercises:

Mat-Hundred: The exercise involved lying on a mat with legs bent and feet flat on the floor. The participant inhales to engage the abdominal muscles, then lifts the head and shoulders off the mat with the eyes between the legs. Arms pump vigorously, lifting up and down no higher than the hips. The exercise was repeated 10 times with 5 inhales and 5 exhales for a total of 100.

Mat-Roll-Up: The participant positioned the legs parallel to the ground, flexed the legs, and extended the arms above the head. Focus on the gaze and position of the arms for a thorough examination. The action includes taking a deep breath, then rolling the body upward. Maintain the C-curve by exhaling forward and lifting the abdomen inward. Rolling shoulder blades down the back ensures the shoulders are relaxed and broad. Inhaling and maintaining the curvature of the spine by lowering the lower back towards the mat.

Mat-one-leg circle: The participant assumed supine, extended one leg vertically towards the ceiling, aligned both legs along the centerline, and secured arms, shoulder blades, pelvis, and head onto the mat. Create a circular shape with the toe, then cross a leg over the body and execute a circular motion below, around, and above. Roll down the shoulder blades while maintaining contact with the mat. Inhale during one cycle and exhale during the next.

Mat-Rolling Like a Ball: The participant demonstrated it by placing his hands crossed, keeping his heels firmly on the floor, and performing a forward curling motion. Then lifts his feet off the mat, keeping his heels close together and his toes slightly apart. Engaging the abdominal muscles, keep the chin lowered toward the chest, and inhale to initiate a backward rolling motion. Maintain a state of equilibrium while rolling up and looking down.

Mat-Spine Stretch: The student sat on his back, chin to chest, and extended his leg while imprinting his spine on the mat. He pressed his shoulder blade tips into the mat, drawing his belly in and up. He then lowered his leg to the ground, touching the calf three times. He inhaled to switch, and he exhaled to lower and touch.

Statistical Analysis

A histogram, drawing box plot, mean, standard deviation, and Shapiro–Wilk test were employed to examine the homogeneity of the observed results. The distribution of all assessed variables (core endurance tests, Prokin indices) showed a parametric distribution. In order to distinguish between and within the measured outcomes, a two-way mixed model MANOVA was employed. The demographic information of the individuals was compared using the unpaired t–test, and the nominal data were compared using the chi-square test. Mean and standard deviation were used to represent quantitative data, and numbers and percentages were used for nominal data. An alpha level of 0.05 or less was set as a significance level. SPSS version 20 was used for all statistical computations.

Results

This study included a total of 145 undergraduate students, consisting of 84 females and 61 males. Figure 1 presents the study flowchart. Table 1 displays the demographic characteristics of the participants. Findings revealed no statistically significant difference between the two groups regarding age, weight, height, BMI, or sex, and the baseline values of the measured outcomes (p ˃ 0.05), as displayed in Tables 1–3.

Table 1 Demographic and Clinical Characteristics of Both Groups

Table 2 Within and Between Groups, Comparisons of the Primary Outcome Measures (Core Endurance Tests)

Table 3 Within and Between Groups, Comparisons of the Secondary Outcome Measures (Prokin System Variables)

After 3 months of exercise, the within-group comparison revealed a significant difference in both the Pilates and control groups in all the tested outcomes (p<0.001). Comparison between groups exhibited an improvement that favored the Pilates group regarding the core endurance tests (p < 0.05), Prokin balance indices OE_Perimeter, OE_Perimeter, and OE_ Ellipse area (p < 0.001); however, there is no difference regarding CE_ Ellipse area (p = 0.062), as shown in Tables 2 and 3.

Discussion

To the best of our knowledge, this is the first study that has been conducted to investigate the effect of pilates exercise on core endurance and static balance after recovery from COVID-19. A 12-week Pilates exercise program showed positive results for core endurance and static balance; therefore, we rejected our null hypothesis regarding the effects of Pilates exercises on core endurance and static balance. For all participants, the baseline scores of the five core endurance tests performed were well below the normal average means, indicating the weakness of the core muscles of the participants included in the study. We used the normal average means from McGill et al for the trunk flexor, trunk extensor, and right and left side plank tests as guides in our study because the characteristics of their sample were similar to ours.29 For the prone plank test, we used the normal values from Strand et al.39 In the Pilates group, the post-scores on the core endurance tests increased by almost twice the pre-training score compared to the control group.

The core endurance improvement could be attributed to that Pilates exercises improve pulmonary function and capacity by engaging the respiratory muscles,40 increasing oxygen delivery to skeletal muscles. Moreover, enhancement of trunk proprioception and trunk control give another clarification of the effect of Pilates training on core endurance, particularly the effect on the local core muscles, which play an important role in improving movement quality, postural balance,41 and neuromuscular efficiency and consequently improve proximal stability.42

Pilates exercises increase the thickness of the transverse abdominis (TrA), internal and external oblique, pelvic floor, and multifidus muscles, as confirmed through ultrasound evaluation after the application of pilates exercises.43,44 These play a key role in trunk stability. In addition, Pilates exercises increase core muscle contraction and intra-abdominal pressure, stabilizing the lumbar spine and pelvis.45,46 This finding was confirmed recently by the Tsartsapakis et al.45 They found that Pilates exercises significantly improved overall TrA thickness and activation in 44 healthy young and middle-aged women, particularly in young women aged 25–35 years. Moreover, the current results are supported by previous studies examining the greatest effects of core stability exercises and Pilates on TrA activation.47–50

Pilates exercises also improve neutral spinal alignment, co-contraction of the pelvic floor and deep abdominal muscles,21 and awareness and coordination of the TrA,45 as supported by a systematic review and meta-analysis that concluded that Pilates exercises performed for 5 to 12 weeks in healthy individuals, showing improved activation of core muscle endurance in both sexes,51 despite being conducted on healthy individuals.

The improvement in core muscle endurance was verified by the Lee study, which analyzed 16 experienced Pilates practitioners and 16 non-experienced subjects using 3D motion analysis. He found that experienced subjects had stronger abdominal and lower back core muscles and better trunk and pelvic stability, with a moderate correlation between experience and core stability.42

The Pilates group showed better static core balance than the control group, as indicated by a significant decrease in perimeter with OE and CE and ellipse area with CE compared to the control group. The decrease in perimeter and ellipse area was higher in OE than CE due to visual information improving the brain’s motor program and replacing the loss of somatosensory function.52

The Prokin system is a valid instrument that was used for evaluation of balance after balance training in people with white matter lesions,33 and stroke patients.53 Their results showed decreased parameters in perimeter and ellipse areas after 2 to 3 weeks of training.

The present results come in agreement with a study that examined the effect of Pilates mat exercise for 12 weeks on static and dynamic balance posture in 20 Korean high school archers using the Humac Norm Balance System. Dividing participants into exercise and control groups showed that only the exercise group showed improvement in both balance postures.38

Previous studies investigated the effect of Pilates mat exercises on pulmonary function and quality of life in COVID-19 patients; recently, Bagherzadeh-Rahmani et al conducted a study on the impact of Pilates and aqua Pilates training on COVID-19 patients, revealing significant improvements in pulmonary function and quality of life, attributing this effect to Pilates’ impact on core muscle endurance and balance.54 Moreover, a recent systematic review conducted on multiple sclerosis patients reported that Pilates exercise improves core stabilization, balance, gait, muscle strength, and aerobic capacity.55

The results of this study provide evidence of decreased core stability as a result of COVID-19 and support what other studies have found about the effects of Pilates. Our study is valuable and has many strengths: the sample size was sufficient to represent the study population; we used an easily clinically applicable and reliable method to assess core endurance using the five core endurance tests; and we used an objective, reliable method for static balance testing. The treatment program of this study lasted for a 12-week period, demonstrating its importance and practical implications in the evaluation and treatment of core muscle endurance and static balance in cases of post-COVID-19 infection. However, there are certain limitations to this study: first, it was not possible to blind the participants; second, it focused on examining only two aspects of core stability (endurance and balance); and third, it did not examine long-term follow-up after Pilates training was discontinued.

Conclusion

The study confirmed the decreased core muscular endurance after recovery from COVID-19 and showed that adding Pilates training to home exercises significantly improved core stability, endurance, and static balance in post-COVID-19 cases.

Data Sharing Statement

The research study’s dataset is not publicly accessible, but can be obtained from the author upon formal request.

Acknowledgments

We are grateful to the students who have recovered from COVID-19 for their participation in this study.

Funding

The study received no specific financial support from public, commercial, or non-profit funding bodies.

Disclosure

The authors report no conflicts of interest in this work.

References

1. Evcik D. Musculoskeletal involvement: COVID-19 and post COVID 19. Turkish J Phys Med Rehabil. 2023;69(1):1–7

2. Novelli G, Biancolella M, Mehrian-Shai R, et al. COVID-19 update: the first 6 months of the pandemic human genomics. Human Genomics. 2020;4:1–9.

3. Akbarialiabad H, Taghrir MH, Abdollahi A, et al. Long COVID, a comprehensive systematic scoping review. Infection. 2021;49(6):1163–1186. doi:10.1007/s15010-021-01666-x

4. Yapici H, Yagin FH, Emlek B, et al. Examining barriers to participation in physical activity: a study of adults. J Exerc Sci Phys Act Rev. 2023;2023:1–11.

5. Montes-Ibarra M, Oliveira CLP, Orsso CE, Landi F, Marzetti E, Prado CM. The impact of long COVID-19 on muscle health, clinics in geriatric medicine. W B Saunders. 2022;38:545–557.

6. Giardini M, Arcolin I, Guglielmetti S, Godi M, Capelli A, Corna S. Balance performance in patients with post-acute COVID-19 compared to patients with an acute exacerbation of chronic obstructive pulmonary disease and healthy subjects. Int J Rehabil Res. 2022;45(1):47–52. doi:10.1097/MRR.0000000000000510

7. Huxel Bliven KC, Anderson BE. Core stability training for injury prevention. Sports Health. 2013;5(6):514–522. doi:10.1177/1941738113481200

8. Hibbs AE, Thompson KG, French D, Wrigley A, Spears I. Optimizing performance by improving core stability and core strength. Sports Med. 2008;38(12):995–1008. doi:10.2165/00007256-200838120-00004

9. Smith CE, Nyland J, Caudill P, Brosky J, Caborn DNM. Dynamic trunk stabilization: a conceptual back injury prevention program for volleyball athletes. J Orthop Sports Phys Ther. 2008;38(11):703–720. doi:10.2519/jospt.2008.2814

10. Rasmussen-Barr E, Nordin M, Skillgate E. Are respiratory disorders risk factors for troublesome neck/shoulder pain? A study of a general population cohort in Sweden. Eur Spine J. 2023;32(2):659–666. doi:10.1007/s00586-022-07509-z

11. Chandan JS, Brown KR, Simms-Williams N, et al. Non-pharmacological therapies for post-viral syndromes, including long COVID: a systematic review. Int J Environ Res Public Health. 2023;16(4):1.

12. Franks J, Thwaites C, Morris ME. Pilates to improve core muscle activation in chronic low back pain: a systematic review. Healthc. 2023;11(10):1.

13. Adıgüzel S, Aras D, Gülü M, Aldhahi MI, Alqahtani AS, AL-Mhanna SB. Comparative effectiveness of 10-week equipment-based pilates and diaphragmatic breathing exercise on heart rate variability and pulmonary function in young adult healthy women with normal BMI – a quasi-experimental study. MC Sports Sci Med Rehabil. 2023;15(1):1.

14. Mayer KP, Steele AK, Soper MK, et al. Physical therapy management of an individual with post-COVID syndrome: a case report. Phys Ther. 2021;1(6):101.

15. Cevei M, Onofrei RR, Gherle A, Gug C, Stoicanescu D. Rehabilitation of post-COVID-19 musculoskeletal sequelae in geriatric patients: a case series study. Int J Environ Res Public Health. 2022;19(22):15350. doi:10.3390/ijerph192215350

16. Ponce-Campos SD, Díaz JM, Moreno-Agundis D, et al. A physiotherapy treatment plan for post-COVID-19 patients that improves the FEV1, FVC, and 6-min walk values, and reduces the sequelae in 12 sessions. Front Rehabil Sci. 2022;3:907603. doi:10.3389/fresc.2022.907603

17. Mashhadi M, Sahebozamani M, Daneshjoo A, Adeli SH. the effect of respiratory and core stability tele-exercises on pulmonary and functional status in COVID-19 survivors: a randomized clinical trial. Phys Treat - Specif Phys Ther J. 2022;12(2):85–92.

18. Patti A, Thornton JS, Giustino V, et al. Effectiveness of Pilates exercise on low back pain: a systematic review with meta-analysis. Disabil Rehabil. 2023;26:1–14. doi:10.1080/09638288.2023.2251404

19. Rydeard R, Leger A, Smith D. Pilates-based therapeutic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial. J Orthop Sports Phys Ther. 2006;36(7):472–484. doi:10.2519/jospt.2006.2144

20. Anderson BD, Spector A Introduction to pilates-based rehabilitation;2024.

21. Wells C, Kolt GS, Marshall P, Bialocerkowski A. The definition and application of pilates exercise to treat people with chronic low back pain: a delphi survey of Australian physical therapists. Phys Ther. 2014;94(6):792–805. doi:10.2522/ptj.20130030

22. Bulguroglu HI, Bulguroglu M. The effects of online pilates and face-to-face pilates in healthy individuals during the COVID-19 pandemic: a randomized controlled study. BMC Sport Sci Med Rehabil. 2023;15(1):12. doi:10.1186/s13102-023-00625-3

23. Pk DS, Sigoli E, Ljg B, As C. The musculoskeletal involvement after mild to moderate COVID-19 infection. Front Mater. 2022;13:1.

24. Yang LL, Yang T. Pulmonary rehabilitation for patients with coronavirus disease 2019 (COVID-19). Chronic Dis Tran Med. 2020;6(2):79–86. doi:10.1016/j.cdtm.2020.05.002

25. Chaves C, Filho RAF, Dutra MAB. Physical therapy rehabilitation after hospital discharge in patients affected by COVID-19: a systematic review. BMC Infect Dis. 2023;23(1):1–9. doi:10.1186/s12879-022-07947-6

26. Schulz KF, Altman DG, Moher D. Consort 2010 statement. Obstet Gynecol. 2010;115(5):1063–1070. doi:10.1097/AOG.0b013e3181d9d421

27. Löllgen H, Bachl N, Papadopoulou T, et al. Recommendations for return to sport during the SARS-CoV-2 pandemic. BMJ Open Sport Exercise Med. 2020;6(1):e000858. doi:10.1136/bmjsem-2020-000858

28. AlAbdulwahab SS, Kachanathu SJ. Effects of body mass index on foot posture alignment and core stability in a healthy adult population. J Exerc Rehabil. 2016;12(3):182–187. doi:10.12965/jer.1632600.300

29. McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999;80(8):941–944. doi:10.1016/S0003-9993(99)90087-4

30. Aggarwal A, Kumar S, Madan R, Kumar R. Relationship among different tests of evaluating low back core stability. J Musculoskelet Res. 2011;14(02):1250004. doi:10.1142/S0218957712500042

31. Waldhelm A, Li L. Endurance tests are the most reliable core stability related measurements. J Sport Heal Sci. 2012;1(2):121–128. doi:10.1016/j.jshs.2012.07.007

32. Wang S, Yang J, Zhu Y. Reliability and validity of static balance measures in hemiplegic patients using balance feedback training equipment. Chinese J Rehabil Med. 2011;26(11):1.

33. You H, Zhang H, Liu J, et al. Effect of balance training with Pro-kin System on balance in patients with white matter lesions. Medicine. 2017;96(51):e9057. doi:10.1097/MD.0000000000009057

34. Donath L, Roth R, Zahner L, Faude O. Testing single and double limb standing balance performance: comparison of COP path length evaluation between two devices. Gait Posture. 2012;36(3):439–443. doi:10.1016/j.gaitpost.2012.04.001

35. Asseman F, Caron O, Crémieux J. Is there a transfer of postural ability from specific to unspecific postures in elite gymnasts? Neurosci Lett. 2004;358(2):83–86. doi:10.1016/j.neulet.2003.12.102

36. Thompson PD, Arena R, Riebe D, Pescatello LS. American college of sports medicine. ACSM’s new preparticipation health screening recommendations from ACSM’s guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013;12(4):215–217. doi:10.1249/JSR.0b013e31829a68cf

37. Marandi SM, Shahnazari Z, Minacian V, Zahed A. A comparison between Pilates exercise and aquatic training effects on mascular strength in women with Mulitple sclorosis. Pak J Med Sci. 2013;29(1 suppl):1.

38. Park JM, Hyun GS, Jee YS. Effects of Pilates core stability exercises on the balance abilities of archers. J Exerc Rehabil. 2016;12(6):553–558. doi:10.12965/jer.1632836.418

39. Strand SL, Hjelm J, Shoepe TC, Fajardo MA. Norms for an isometric muscle endurance test. J Hum Kinet. 2014;40(1):93–102. doi:10.2478/hukin-2014-0011

40. Endleman I, Critchley DJ. Transversus abdominis and obliquus internus activity during pilates exercises: measurement with ultrasound scanning. Arch Phys Med Rehabil. 2008;89(11):2205–2212. doi:10.1016/j.apmr.2008.04.025

41. Suner-Keklik S, Numanoglu-Akbas A, Cobanoglu G, Kafa N, Guzel NA. An online pilates exercise program is effective on proprioception and core muscle endurance in a randomized controlled trial. Ir J Med Sci. 2022;191(5):2133–2139. doi:10.1007/s11845-021-02840-8

42. Lee K. The relationship of trunk muscle activation and core stability: a biomechanical analysis of pilates-based stabilization exercise. Int J Environ Res Public Health. 2021;18(23):12804. doi:10.3390/ijerph182312804

43. Giacomini MB, da Silva AMV, Weber LM, Monteiro MB. The pilates method increases respiratory muscle strength and performance as well as abdominal muscle thickness. J Bodyw Mov Ther. 2016;20(2):258–264. doi:10.1016/j.jbmt.2015.11.003

44. Gala-Alarcón P, Calvo-Lobo C, Serrano-Imedio A, Garrido-Marín A, Martín-Casas P, Plaza-Manzano G. Ultrasound evaluation of the abdominal wall and lumbar multifidus muscles in participants who practice pilates: a 1-year follow-up case series. J Manipulative Physiol Ther. 2018;41(5):434–444. doi:10.1016/j.jmpt.2017.10.007

45. Tsartsapakis I, Gerou M, Zafeiroudi A, Kellis E. Transversus abdominis ultrasound thickness during popular trunk-pilates exercises in young and middle-aged women. J Funct Morphol Kinesiol. 2023;8(3):250.

46. Ali OI, Abdelraouf OR, El-Gendy AM, et al. Efficacy of telehealth core exercises during COVID-19 after bariatric surgery: a randomized controlled trial. Eur J Phys Rehabil Med. 2022;58(6):845–852. doi:10.23736/S1973-9087.22.07457-3

47. Imai A, Kaneoka K, Okubo Y, et al. Trunk muscle activity during lumbar stabilization exercises on both a stable and unstable surface. J Orthop Sports Phys Ther. 2010;40(6):369–375. doi:10.2519/jospt.2010.3211

48. Okubo Y, Kaneoka K, Mai A, et al. Electromyographic analysis of transversus abdominis and lumbar multifidus using wire electrodes during lumbar stabilization exercises. J Orthop Sports Phys Ther. 2010;40(11):743–750. doi:10.2519/jospt.2010.3192

49. Emami F, Pirouzi S, Taghizadeh S. Comparison of abdominal and lumbar muscles electromyography activity during two types of stabilization exercises. Zahedan J Res Med Sci. 2015;17(4). doi:10.5812/zjrms.17(4)2015.963

50. Moghadam N, Ghaffari MS, Noormohammadpour P, et al. Comparison of the recruitment of transverse abdominis through drawing-in and bracing in different core stability training positions. J Exerc Rehabil. 2019;15(6):819–825. doi:10.12965/jer.1939064.352

51. Campos RR, Dias JM, Pereira LM, et al. Effect of the Pilates method on physical conditioning of healthy subjects: a systematic review and meta-analysis. J Sports Med Phys Fitness. 2016;56(7–8):864–873.

52. Mulder T, Hulstyn W. Sensory feedback therapy and theoretical knowledge of motor control and learning. Am J Phys Med. 1984;63(5):226–244.

53. Zhang M, You H, Zhang H, et al. Effects of visual feedback balance training with the Pro-kin system on walking and self-care abilities in stroke patients. Medicine. 2020;99(39):1.

54. Bagherzadeh-Rahmani B, Kordi N, Haghighi AH, et al. Eight weeks of pilates training improves respiratory measures in people with a history of COVID-19: a preliminary study. Sports Health. 2023;15(5):710–717. doi:10.1177/19417381221124601

55. Rodríguez-Fuentes G, Silveira-Pereira L, Ferradáns-Rodríguez P, Campo-Prieto P. Therapeutic effects of the pilates method in patients with multiple sclerosis: a systematic review. J Clin Med. 2022;11(3):683. doi:10.3390/jcm11030683

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Ying Wang,1,&ast; Yu Yi,1,&ast; Fan Zhang,1 Yuan-Yuan Yao,2 Yue-Xiu Chen,2 Chao-Min Wu,2 Rui-Yu Wang,2 Min Yan1,2

1Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, 221004, People’s Republic of China; 2Department of Anesthesiology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310016, People’s Republic of China

Background: The lung ultrasound score was developed for rapidly assessing the extent of lung ventilation, and it can predict failure to wean various types of patients off mechanical ventilation. Whether it is also effective for COVID-19 patients is unclear.
Methods: This single-center, prospective, observational study was conducted to assess the ability of the 12-region lung ultrasound score to predict failure to wean COVID-19 patients off ventilation. In parallel, we assessed whether right hemidiaphragmatic excursion or previously published predictors of weaning failure can apply to these patients. Predictive ability was assessed in terms of the area under the receiver operating characteristic curve (AUC).
Results: The mean age of the 35 patients in the study was (75 ± 9) years and 12 patients (37%) could not be weaned off mechanical ventilation. The lung ultrasound score predicted these failures with an AUC of 0.885 (95% CI 0.770– 0.999, p < 0.001), and a threshold score of 10 provided specificity of 72.7% and sensitivity of 92.3%. AUCs were lower for previously published predictors of weaning failure, and right hemidiaphragmatic excursion did not differ significantly between the two groups.
Conclusion: The lung ultrasound score can accurately predict failure to wean critically ill COVID-19 patients off mechanical ventilation, whereas assessment of right hemidiaphragmatic excursion does not appear helpful in this regard.
Trial Registration: clinicaltrials.gov/ct2/show/NCT05706441.

Keywords: lung ultrasound score, diaphragmatic excursion, spontaneous breathing trial, weaning, COVID-19, critical care

Background

The COVID-19 pandemic substantially increased numbers of patients admitted to the intensive care unit for respiratory failure, especially in the elderly, where the mortality rate among such patients can exceed 30%.1,2 Many COVID-19 patients require mechanical ventilation longer than 2–3 weeks.3 During the intensive care of these and other types of patients, clinicians face the difficult decision of whether to halt or continue mechanical ventilation: clinicians may prefer to continue it until the patient’s condition improves, but prolonged respiratory support increases risk of complications such as bacterial pneumonia and barotrauma with alveolar rupture, while occupying limited intensive care resources.4

Weaning off mechanical ventilation may fail for up to 20% of patients without COVID-19 or up to 40% of patients with COVID-19.5,6 Reliable prediction of which patients can or cannot be weaned off mechanical ventilation would help clinicians provide effective care and optimize the use of limited medical resources. Several predictors of weaning failure have been proposed, and perhaps the most widely used is the rapid shallow respiratory index (RSBI).7 RSBI was calculated as described by dividing breathing frequency by tidal volume. Others include the lung ultrasound score, which assesses pulmonary ventilation based on ultrasound images; and diaphragmatic excursion, in which the diaphragm is visualized through subcostal ultrasound.8,9 These predictors were developed before the COVID-19 pandemic, and whether they apply to COVID-19 patients is unclear. The RSBI, in particular, becomes less reliable for patients on prolonged mechanical ventilation, which is the situation for many critically ill COVID-19 patients.10

Here, we assessed whether the lung ultrasound score can reliably predict failure to wean COVID-19 patients off mechanical ventilation. We focused on this score because the pneumonia lesions in such patients can easily be monitored using ultrasound.11 We also assessed the predictive ability of diaphragmatic excursion, respiratory rate, and shallow fast breathing index.

Methods

Patients

For this prospective observational trial, we enrolled patients who (1) were admitted between January 11, 2023, and March 30, 2023, to the intensive care unit at our university-affiliated tertiary care medical center; (2) tested positive, at the time of admission, for the causative SARS-CoV-2 virus based on PCR analysis of nasopharyngeal or bronchoalveolar samples, alongside observed abnormalities like ground-glass shadows on chest computed tomography (Supplementary Figure S1); (3) were older than 18 years; (4) required mechanical ventilation due to respiratory failure; and (5) were judged by the attending physician to be able to undergo a spontaneous breathing test because the causes of intubation had sufficiently improved or resolved. Patients were excluded if they had flail chest or rib fractures, neuromuscular disease, or stridor indicating upper airway involvement.

Spontaneous Breathing Test and Weaning

During the spontaneous breathing test, enrolled patients were subjected to a pressure support ventilation of 8 cmH2O and a small amount of applied PEEP (4 to 5 cmH2O), while maintaining the same fractional inspired oxygen as during mechanical ventilation, for a duration of 60 minutes. At 30 min after starting the test, ultrasound assessments were performed to enable determination of the lung ultrasound score and diaphragmatic excursion (see next section). All manipulations were done during spontaneous breathing of the patient. Blood gases were also analyzed.

Patients were considered to pass the spontaneous breathing test unless they showed one of the following: altered mental status, malaise, sweating, respiratory rate above 35 beats/minute, heart rate > 140 and/or systolic blood pressure > 180 or < 90 mmHg, or obvious signs of extreme labor during breathing.12 Weaning failure was defined as failure in the spontaneous breathing test, or the need for non-invasive or mechanical ventilation or death within 48 h after passing the test.13

Attending physicians who were not involved in the study and who were unaware of ultrasound findings decided whether patients failed the spontaneous breathing test or required ventilation after passing the test.

Ultrasonography

All ultrasonography was performed by a trained researcher using an M9 system (Mindray, Shenzhen, Guangdong, China). For ultrasound imaging of the lung, patients were in the supine position with the head of the bed raised 10–15° and 12-region imaging was conducted (Supplementary Figure S2). In each hemithorax, the parasternal, anterior axillary, and posterior axillary lines were used to identify anterior, lateral and posterior areas, each of which was subdivided into upper and lower halves.14,15 A convex 3–5 MHz probe was used to assess aeration loss in each intercostal space according to a four-point scale: 0 indicated normal aeration, defined as the presence of A lines and one or two isolated vertical B lines; 1 indicated moderate loss of lung ventilation, defined as multiple well-defined B1 lines; 2 indicated severe loss of lung ventilation, defined as multiple fused vertical B lines; and 3 indicated alveolar consolidation (Supplementary Figure S3). For each region of interest, the worst score for aeration loss among the images was used, and the scores for all 12 regions were summed to obtain a total score (maximal possible: 36). Lung ultrasound imaging and calculation of the total score took 10–15 min.

For ultrasound imaging of the diaphragm, patients were in a semi-recumbent position with the head of the bed raised 20–30°. The 3–5 MHz probe was placed on the mid-clavicular line below the right subcostal margin, and it was finely repositioned to optimize imaging of the posterior third of the right diaphragm. Imaging in M-mode was performed during tidal breathing such that diaphragmatic excursion could be visualized along a selected line perpendicular to the diaphragm. The excursion was defined as the distance from baseline on the vertical axis to the height at maximum inspiration during a breathing cycle (Supplementary Figure S4). The excursion was defined as the average from at least three measurements. Diaphragm imaging and calculation of excursion took 5–10 min.

Data Collection

After admission to the intensive care unit and before the spontaneous breathing test, each patient underwent a standard medical examination, including medical history, acute physiology and chronic health evaluation II, determination of the sequential organ failure assessment score and assays of procalcitonin, interleukin (IL)-6 and cardiac troponin in plasma. Either troponin I or high-sensitivity troponin T was assayed because both reflect myocardial damage, which was defined here as a level above the 99th percentile reference limit.16 Data were also collected on respiratory rate, tidal volume, and fractional inspired oxygen as determined by the ventilator. RSBI was calculated as described.17 Durations of mechanical ventilation were recorded.

Sample Size

We speculated a weaning failure rate of 35% based on previous studies, and we defined a minimal acceptable area under the receiver operator characteristic curve (AUC) to be 0.80 for predicting failure.18 Based on a type I error rate of 0.10 and power of 0.9, we calculated a minimal sample of 31 patients, which we increased to 35 to allow for up to 10% loss to follow-up.

Statistical Analysis

Continuous data were presented as mean ± standard deviation (SD) if normally distributed, or as median and interquartile range (IQR) if skewed. Categorical data were reported as absolute or relative frequencies (%). Intergroup differences in continuous data were assessed for significance using unpaired Student’s t, Mann–Whitney, or paired Wilcoxon tests. Intergroup differences in categorical data were assessed using chi-squared or Fisher’s exact tests.

The predictive accuracy of the lung ultrasound score, respiratory rate or RSBI was assessed in terms of AUCs. The optimal cut-off values were determined using Youden’s index, then the corresponding sensitivity, specificity and other indicators of diagnostic performance were calculated. In addition to assessing predictive performance using a point cut-off, we estimated likelihood ratios using inconclusive limits, with ratios >10 or <0.2 defined as clinically valuable.19

Factors associated with weaning failure were identified using Spearman’s rank correlation. Elements with p < 0.05 in the significance variables of univariate analysis were included in multivariate logistic regression analysis.

SPSS 20.0 (IBM, Armonk, NY, USA) software was used for statistical analysis, and GraphPad Prism 9 (San Diego, CA, USA) was used for graphing. Results with p < 0.05 were considered significant.

Results

Of the 39 patients initially screened for enrollment, 35 were included in the study (Figure 1). All patients completed ultrasound imaging of the lung, but seven did not complete imaging of the diaphragm because they were unable to cooperate during the operation (2 patients) or they had abdominal distension (5 patients). The minimum age of the patients was 60 years, and the mean age was 75 ± 9 years (Table 1). Median duration of mechanical ventilation until the spontaneous breathing test was 14 days (IQR 9, 21 days) (Table 2).

Figure 1 Flowchart of patient enrollment and outcomes. Map was created using WPS Office 3 (Kingsoft Corporation, Beijing, China).

Abbreviations: MV, mechanical ventilation; SBT, spontaneous breathing test.

Table 1 Clinicodemographic Characteristics of Study Participants, Stratified by Whether They Were Weaned off Mechanical Ventilation

Table 2 Clinical and Spirometric Characteristics of the Overall Population and of Successfully and Unsuccessfully Weaned Patients

Among the 35 patients, 13 could not be weaned off mechanical ventilation: five of those patients failed the spontaneous breathing test because of tachypnea or evident dyspnea, and the remaining eight passed the breathing test but had to resume mechanical ventilation within 48 h due to hemodynamic instability (2 patients) or progressive dyspnea (6 patients).

Compared to patients who could be weaned off mechanical ventilation, those who failed showed the following significant differences: higher procalcitonin level, higher lung ultrasound score, higher respiratory rate, and higher RSBI (Table 2). In contrast, diaphragmatic excursion did not differ significantly between the two groups.

Lung ultrasound score gave the best AUC for predicting weaning failure AUC 0.885, 95% CI 0.770–0.999), followed by RSBI (AUC 0.787, 95% CI 0.623, 0.950) and finally respiratory rate (AUC 0.715, 95% CI 0.514, 0.916) (Figure 2A, Table 3). A cut-off lung ultrasound score of 10 gave sensitivity of 92.3% and specificity of 72.7%. To assess predictive ability more comprehensively than with a point cut-off, we estimated inconclusive limits as described.19 Lung ultrasound scores >14 emerged as highly specific for predicting weaning failure, while scores <10 were highly sensitive for excluding weaning failure (Table 4, Figure 2B). The corresponding analysis of respiratory rate and RSBI led to likelihood ratios that were not clinically valuable (Supplementary Table S1).

Figure 2 Area under the curve of the predictive index and inconclusive limits. (A) Receiver operating characteristic curves to assess the ability of lung ultrasound score (LUS), respiratory rate (RR) or rapid shallow breathing index (RSBI) to predict weaning failure. The curves were generated by Prism 9 software and used to determine the AUC (area under the curve) for each predictor. (B) Inconclusive limits on the ability of lung ultrasound score to predict weaning failure. Limits were calculated as described in Ray et al.19 Map was created using Prism 9 software.

Table 3 Performance of Different Indicators in Predicting Weaning Failure

Table 4 Likelihood Ratios Describing the Ability of Different Ranges of the Lung Ultrasound Score to Predict Weaning Failure

As a potential alternative to the 12-region lung ultrasound score, we explored the predictive ability of an 8-region score calculated by summing the subscores for the anterior chest and lateral thoracic regions. We obtained an AUC of 0.832 (p < 0.001, Supplementary Figure S5).

Univariate analysis identified lung ultrasound score, respiratory rate and RSBI as significantly associated with weaning failure (Table 2), but multivariate regression identified lung ultrasound score as the only independent predictor (Table 5). The same result was obtained whether we included RSBI or respiratory rate in the multivariate model. We did not include the two together in one model because they correlated with each other (r = 0.79, p < 0.001; Supplementary Figure S6).

Table 5 Multiple Logistic Regression to Identify Independent Predictors of Weaning Failure

Discussion

In this prospective study focusing on critically ill mechanically ventilated patients afflicted with COVID-19, a striking demographic trend emerged – all our study participants were aged 60 years or older. This unforeseen but notable skew towards an older demographic was accompanied by a high prevalence of comorbidities, particularly hypertension, which was observed in approximately half of our patients (48.5%). This observation is consistent with a large body of literature that agrees that advanced age is an important risk factor for adverse COVID-19 outcomes.3,20 Older adults are known to undergo age-related changes in immune function, as well as a higher prevalence of comorbidities, which makes them more susceptible to the severe effects of the virus.21

Consistent with previous literature, our study reports a very high weaning failure rate of 37%.6,18 Our study suggests that calculating the lung ultrasound score after 30 min of spontaneous breathing can accurately predict whether a critically ill COVID-19 patient is ready to be weaned or not off mechanical ventilation. Two other previously published predictors of weaning failure, respiratory rate and RSBI, did not perform as well as lung ultrasound score. Diaphragmatic excursion was not useful for predicting weaning failure in our cohort, though this result should be interpreted carefully given that we were able to measure it in only 28 patients.

In our sample, the best cut-off value for lung ultrasound scores to predict unsuccessful weaning was ≥10, which is comparable to previous studies in elderly intensive care patients without COVID-19.22,23 Nevertheless, the cut-off of 10 in our study is lower than that of 13 in one of those studies,23 perhaps reflecting the greater mean age in our sample (75 vs 60 years) and, therefore, age-related reductions in rib mobility and volume per breath,24 lung elasticity and alveolar surface area,25 angiogenesis and vascular elasticity,26,27 as well as ATP production and energy reserves.28 It may also reflect pulmonary damage due to SARS-CoV-2.29,30 Furthermore, our study revealed that a lung ultrasound score of less than 10 indicates a significantly low risk of weaning failure, whereas scores exceeding 14 suggest a considerably high risk. Thus, we recommend that patients with a lung ultrasound score greater than 14 receive extended mechanical ventilation. Thille et al31 demonstrated the efficacy of prophylactic noninvasive mechanical ventilation post-extubation in reducing failure rates among high-risk non-COVID-19 patients. This finding has been recently corroborated by a network meta-analysis.32 Considering the heightened risk of weaning failure indicated by high LUS in COVID-19 patients, exploring the prophylactic use of noninvasive mechanical ventilation may be beneficial.

Transthoracic lung ultrasonography is reliable, accurate and non-invasive, and it can easily be performed at the bedside, giving it numerous advantages over traditional radiological methods for assessing lung ventilation.33 However, ultrasound has its inherent limitations. Assessing obese patients presents challenges due to the thickness of subcutaneous tissue in the rib cage. The presence of subcutaneous emphysema or extensive chest dressings can preclude the transmission of ultrasound beams to the lungs. Although the accuracy of ultrasonography depends on the operator’s proficiency and experience, lung ultrasonography can be performed accurately even by residents after approximately 25 supervised measurements.34 In addition, our analysis suggests that the 8-region lung ultrasound score may provide a reasonable alternative to the 12-region score for patients who are difficult to move.

In contrast to lung ultrasonography, diaphragmatic ultrasound using the anterior subcostal approach did not reveal useful differences that could help predict weaning failure in our critically ill COVID-19 patients. In addition, the necessary imaging could not be performed in several of our patients because of abdominal distention. This may reflect that all patients received enteral nutrition, consistent with international guidelines,35 and such nutrition can cause abdominal distension in two-thirds of critically ill COVID-19 patients.36 This distention may reflect direct gastrointestinal effects of SARS-CoV-2 and gastrointestinal dyskinesia due to heavy use of sedatives and prolonged mechanical ventilation.37,38

Two patients in our study developed diaphragmatic paralysis, which has been associated with longer weaning times and higher rates of weaning failure.8 The two patients in our study had 12-region lung ultrasound scores of 15 and 17, and both failed to be weaned during the study.

Our study found RSBI to exhibit inadequate predictive performance and therefore it should not be used as a stand-alone test in COVID-19 patients. Rather surprisingly, in our patients with failed weaning, the RSBI (55 breaths/min/L) was significantly lower than the threshold of 105 reported by Yang and Tobin in their original study predicting weaning failure.39 However, this is not an isolated occurrence, as one meta-analysis reported diverse predictive values for RSBI, likely attributed to differences in study methods, outcome classifications, and patient populations.7

In our cohort, the inflammatory parameter procalcitonin was significantly higher among patients who failed to be weaned than among those who were weaned, consistent with a previous study linking higher procalcitonin to more severe COVID-19.40 However, procalcitonin level did not predict weaning failure in our multivariate analysis. IL-6, whose elevation has been linked to more severe COVID-19 and worse outcomes,41 did not differ significantly between our patients who failed to be weaned and those who were weaned. Thus, our findings are not entirely consistent with previous reports that markers of infection and inflammation are also associated with weaning success.42,43 This may reflect our small sample. Further research is needed to clarify the association of inflammatory markers with weaning outcomes in COVID-19 patients. For example, studies should clarify whether elevated procalcitonin is part of an inflammatory syndrome associated with COVID-19, or it indicates concurrent bacterial infection requiring antibiotic therapy.44

Our results should be generalized carefully in light of the characteristics of our cohort. Just over one-third of patients underwent tracheostomy, which is recommended for patients requiring long-term mechanical ventilation.45 Rate of weaning failure did not differ significantly between patients who underwent tracheostomy or not (Table 1). Furthermore, the inclusion of patients with tracheal intubation and tracheotomy enhances the generalizability and external validity of our study findings. As these interventions are integral to the management of severe COVID-19 cases, omitting them from the study could limit the applicability of our conclusions to the broader patient population. Whether our findings are also applicable to younger COVID-19 critically ill patients remains needs to be explored. Indeed, our findings should be validated on a larger scale, preferably in a multisite population.

Future work should also assess cardiac function during the spontaneous breathing test. Since some weaning failures among COVID-19 patients are due to acute heart failure rather than respiratory failure, studies should explore whether combining cardiac function with lung ultrasonography improves prediction of weaning failure.

Conclusion

Our study not only advances our understanding of age-related vulnerabilities in the face of COVID-19 but also underscores the potential of lung ultrasound as a pivotal tool in guiding the weaning process for critically ill elderly patients. In our cohort, scores <10 predicted successful weaning, while scores >14 predicted failure. Our data suggest that measurement of diaphragmatic excursion is of limited usefulness for predicting weaning failure among these patients.

Abbreviations

AUC, Area under the curves; COVID-19, Coronavirus disease 2019; IL-6, Interleukin-6; RSBI, Rapid shallow breathing index.

Data Sharing Statement

The datasets in this study are available from the corresponding author on reasonable request.

Ethics Approval and Consent to Participate

The trial was approved by the Institutional Review Board of the Second Affiliated Hospital of the Medical College of Zhejiang University (IR2023-0020) and conducted in accordance with Good Clinical Practice and the Declaration of Helsinki. Informed consent was obtained from the legal guardians of all study participants.

Acknowledgments

Ying Wang and Yu Yi are co-first authors for this study. We sincerely thank the intensive care staff for their hard work.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

This work was supported by the National Clinical Key Specialty Construction Project of China (2021-LCZDZK-01); Leading Health Talents of Zhejiang Province, Zhejiang Health Office No. 18(2020); and Key Laboratory of The Diagnosis and Treatment of Severe Trauma and Burn of Zhejiang Province.

Disclosure

The authors declare that they have no competing interests in this work.

References

1. Tyrrell CSB, Mytton OT, Gentry SV, et al. Managing intensive care admissions when there are not enough beds during the COVID-19 pandemic: a systematic review. Thorax. 2021;76(3):302–312. doi:10.1136/thoraxjnl-2020-215518

2. Auld SC, Caridi-Scheible M, Blum JM, et al. ICU and ventilator mortality among critically ill Adults with Coronavirus Disease 2019. Crit Care Med. 2020;48(9):e799–e804. doi:10.1097/CCM.0000000000004457

3. African C-CCOSI. Patient care and clinical outcomes for patients with COVID-19 infection admitted to African high-care or intensive care units (ACCCOS): a multicentre, prospective, observational cohort study. Lancet. 2021;397(10288):1885–1894. doi:10.1016/S0140-6736(21)00441-4

4. Brandi N, Ciccarese F, Rimondi MR, et al. An imaging overview of COVID-19 ARDS in ICU patients and its complications: a pictorial review. Diagnostics. 2022;12(4):846.

5. Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013;187(12):1294–1302. doi:10.1164/rccm.201208-1523CI

6. Vetrugno L, Orso D, Corradi F, et al. Diaphragm ultrasound evaluation during weaning from mechanical ventilation in COVID-19 patients: a pragmatic, cross-section, multicenter study. Respir Res. 2022;23(1):210. doi:10.1186/s12931-022-02138-y

7. Trivedi V, Chaudhuri D, Jinah R, et al. The usefulness of the rapid shallow breathing index in predicting successful extubation: a systematic review and meta-analysis. Chest. 2022;161(1):97–111. doi:10.1016/j.chest.2021.06.030

8. Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011;39(12):2627–2630. doi:10.1097/CCM.0b013e3182266408

9. Mongodi S, De Luca D, Colombo A, et al. Quantitative lung ultrasound: technical aspects and clinical applications. Anesthesiology. 2021;134(6):949–965. doi:10.1097/ALN.0000000000003757

10. Verceles AC, Diaz-Abad M, Geiger-Brown J, Scharf SM. Testing the prognostic value of the rapid shallow breathing index in predicting successful weaning in patients requiring prolonged mechanical ventilation. Heart Lung. 2012;41(6):546–552. doi:10.1016/j.hrtlng.2012.06.003

11. Shi H, Han X, Jiang N, et al. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020;20(4):425–434. doi:10.1016/S1473-3099(20)30086-4

12. Boles JM, Bion J, Connors A, et al. Weaning from mechanical ventilation. Eur Respir J. 2007;29(5):1033–1056. doi:10.1183/09031936.00010206

13. Schmidt GA, Girard TD, Kress JP, et al. Official Executive Summary of an American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: liberation from mechanical ventilation in critically ill adults. Am J Respir Crit Care Med. 2017;195(1):115–119. doi:10.1164/rccm.201610-2076ST

14. Volpicelli G, Elbarbary M, Blaivas M, et al. International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012;38(4):577–591. doi:10.1007/s00134-012-2513-4

15. Hansell L, Milross M, Delaney A, Koo CM, Tian DH, Ntoumenopoulos G. Quantification of changes in lung aeration associated with physiotherapy using lung ultrasound in mechanically ventilated patients: a prospective cohort study. Physiotherapy. 2022;119:26–33. doi:10.1016/j.physio.2022.11.003

16. Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019;40(3):237–269. doi:10.1093/eurheartj/ehy462

17. Song J, Qian Z, Zhang H, et al. Diaphragmatic ultrasonography-based rapid shallow breathing index for predicting weaning outcome during a pressure support ventilation spontaneous breathing trial. BMC Pulm Med. 2022;22(1):337. doi:10.1186/s12890-022-02133-5

18. Corradi F, Vetrugno L, Orso D, et al. Diaphragmatic thickening fraction as a potential predictor of response to continuous positive airway pressure ventilation in Covid-19 pneumonia: a single-center pilot study. Respir Physiol Neurobiol. 2021;284:103585. doi:10.1016/j.resp.2020.103585

19. Ray P, Le Manach Y, Riou B, Houle TT. Statistical evaluation of a biomarker. Anesthesiology. 2010;112(4):1023–1040. doi:10.1097/ALN.0b013e3181d47604

20. Zheng Z, Peng F, Xu B, et al. Risk factors of critical & mortal COVID-19 cases: a systematic literature review and meta-analysis. J Infect. 2020;81(2):e16–e25. doi:10.1016/j.jinf.2020.04.021

21. Su K, Jin K. Aging during the pandemic: untangling the complexities of COVID-19 and geriatric care. Aging Dis. 2023;14(3):572–576. doi:10.14336/AD.2023.0405

22. Li S, Chen Z, Yan W. Application of bedside ultrasound in predicting the outcome of weaning from mechanical ventilation in elderly patients. BMC Pulm Med. 2021;21(1):217. doi:10.1186/s12890-021-01605-4

23. Soummer A, Perbet S, Brisson H, et al. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012;40(7):2064–2072. doi:10.1097/CCM.0b013e31824e68ae

24. Skloot GS. The effects of aging on lung structure and function. Clin Geriatr Med. 2017;33(4):447–457. doi:10.1016/j.cger.2017.06.001

25. Schulte H, Muhlfeld C, Brandenberger C. Age-related structural and functional changes in the mouse lung. Front Physiol. 2019;10:1466. doi:10.3389/fphys.2019.01466

26. Jane-Wit D, Chun HJ. Mechanisms of dysfunction in senescent pulmonary endothelium. J Gerontol a Biol Sci Med Sci. 2012;67(3):236–241. doi:10.1093/gerona/glr248

27. Schneider JL, Rowe JH, Garcia-de-Alba C, Kim CF, Sharpe AH, Haigis MC. The aging lung: physiology, disease, and immunity. Cell. 2021;184(8):1990–2019. doi:10.1016/j.cell.2021.03.005

28. Desler C, Hansen TL, Frederiksen JB, Marcker ML, Singh KK, Juel Rasmussen L. Is there a link between mitochondrial reserve respiratory capacity and aging? J Aging Res. 2012;2012:192503. doi:10.1155/2012/192503

29. D’Agnillo F, Walters KA, Xiao Y, et al. Lung epithelial and endothelial damage, loss of tissue repair, inhibition of fibrinolysis, and cellular senescence in fatal COVID-19. Sci Transl Med. 2021;13(620):eabj7790. doi:10.1126/scitranslmed.abj7790

30. Doglioni C, Ravaglia C, Chilosi M, et al. Covid-19 interstitial pneumonia: histological and immunohistochemical features on cryobiopsies. Respiration. 2021;100(6):488–498. doi:10.1159/000514822

31. Thille AW, Muller G, Gacouin A, et al. Effect of postextubation high-flow nasal oxygen with noninvasive ventilation vs high-flow nasal oxygen alone on reintubation among patients at high risk of extubation failure: a randomized clinical trial. JAMA. 2019;322(15):1465–1475. doi:10.1001/jama.2019.14901

32. Boscolo A, Pettenuzzo T, Sella N, et al. Noninvasive respiratory support after extubation: a systematic review and network meta-analysis. Eur Respir Rev. 2023;32(168):220196.

33. Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019;199(6):701–714. doi:10.1164/rccm.201802-0236CI

34. Rouby JJ, Arbelot C, Gao Y, et al. Training for lung ultrasound score measurement in critically ill patients. Am J Respir Crit Care Med. 2018;198(3):398–401. doi:10.1164/rccm.201802-0227LE

35. Warren M, McCarthy MS, Roberts PR. Practical application of the revised guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: a case study approach. Nutr Clin Pract. 2016;31(3):334–341. doi:10.1177/0884533616640451

36. Liu R, Paz M, Siraj L, et al. Feeding intolerance in critically ill patients with COVID-19. Clin Nutr. 2022;41(12):3069–3076. doi:10.1016/j.clnu.2021.03.033

37. Lamers MM, Beumer J, van der Vaart J, et al. SARS-CoV-2 productively infects human gut enterocytes. Science. 2020;369(6499):50–54. doi:10.1126/science.abc1669

38. Reintam Blaser A, Preiser JC, Fruhwald S, et al. Gastrointestinal dysfunction in the critically ill: a systematic scoping review and research agenda proposed by the section of metabolism, endocrinology and nutrition of the European Society of Intensive Care Medicine. Crit Care. 2020;24(1):224. doi:10.1186/s13054-020-02889-4

39. Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991;324(21):1445–1450. doi:10.1056/NEJM199105233242101

40. Jackson I, Jaradeh H, Aurit S, et al. Role of procalcitonin as a predictor of clinical outcomes in hospitalized patients with COVID-19. Int J Infect Dis. 2022;119:47–52. doi:10.1016/j.ijid.2022.03.044

41. Burke H, Freeman A, Cellura DC, et al. Inflammatory phenotyping predicts clinical outcome in COVID-19. Respir Res. 2020;21(1):245. doi:10.1186/s12931-020-01511-z

42. Alladina JW, Levy SD, Hibbert KA, et al. Plasma concentrations of soluble suppression of tumorigenicity-2 and interleukin-6 are predictive of successful liberation from mechanical ventilation in patients with the acute respiratory distress syndrome. Crit Care Med. 2016;44(9):1735–1743. doi:10.1097/CCM.0000000000001814

43. Fleuren LM, Dam TA, Tonutti M, et al. Predictors for extubation failure in COVID-19 patients using a machine learning approach. Crit Care. 2021;25(1):448. doi:10.1186/s13054-021-03864-3

44. Vanhomwegen C, Veliziotis I, Malinverni S, et al. Procalcitonin accurately predicts mortality but not bacterial infection in COVID-19 patients admitted to intensive care unit. Ir J Med Sci. 2021;190(4):1649–1652. doi:10.1007/s11845-020-02485-z

45. McGrath BA, Brenner MJ, Warrillow SJ, et al. Tracheostomy in the COVID-19 era: global and multidisciplinary guidance. Lancet Respir Med. 2020;8(7):717–725. doi:10.1016/S2213-2600(20)30230-7

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Experts at the University of Edinburgh partnered with the University of Manchester to study a type of graphene – which is the world’s thinnest, super-strong and super-flexible material.

The researchers say they were able to determine that inhalation of the substance has no short-term adverse effects on the lungs or cardiovascular function.

It marked the first controlled exposure clinical trial of its kind, which used ultra-pure graphene oxide, which is a water compatible form of the material.

The researchers recruited 14 volunteers to take part in the study, who breathed in the material through a face mask for two hours while cycling in an exposure chamber.

Effects on the lungs, blood pressure, blood clotting and inflammation in the blood were monitored, before the exposure and at two-hour intervals.

The volunteers returned two weeks later for further experimentation.

Researchers concluded there were no negative effects on the lungs, blood pressure or all other areas examined.

They did notice a slight suggestion that inhalation of the material can change how the blood clots, but emphasised this was “very small”.

Researchers said they would need to further experiment with the substance to see if longer exposure poses a risk to health, and if other forms of graphene are dangerous to humans.

Graphene was first synthesised in 2004 by scientists, who hailed the substance a “wonder” material.

It is a form of carbon, consisting of a single layer of atoms in a hexagonal lattice.

Scientists around the world are actively studying graphene to see if it can assist with cancer and other health conditions.

Dr Mark Miller, of the University of Edinburgh’s Centre for Cardiovascular Science, said: “Nanomaterials such as graphene hold such great promise, but we must ensure they are manufactured in a way that is safe before they can be used more widely in our lives.

“Being able to explore the safety of this unique material in human volunteers is a huge step forward in our understanding of how graphene could affect the body.

“With careful design we can safely make the most of nanotechnology.”

Professor Kostas Kostarelos, of the University of Manchester and the Catalan Institute of Nanoscience and Nanotechnology in Barcelona, added: “This is the first-ever controlled study involving healthy people to demonstrate that very pure forms of graphene oxide – of a specific size distribution and surface character – can be further developed in a way that would minimise the risk to human health.

“It has taken us more than 10 years to develop the knowledge to carry out this research, from a materials and biological science point of view, but also from the clinical capacity to carry out such controlled studies safely by assembling some of the world’s leading experts in this field.”

Professor Bryan Williams, chief scientific and medical officer at the British Heart Foundation, said: “The discovery that this type of graphene can be developed safely, with minimal short-term side effects, could open the door to the development of new devices, treatment innovations and monitoring techniques.

“We look forward to seeing larger studies over a longer timeframe to better understand how we can safely use nanomaterials like graphene to make leaps in delivering lifesaving drugs to patients.”



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Graphene Danger Art Concept

Recent research indicates that controlled inhalation of ultra-pure graphene oxide does not have short-term adverse effects on human lung or cardiovascular health, marking a significant step in safely harnessing graphene’s potential for various applications. Credit: SciTechDaily.com

A revolutionary nanomaterial with huge potential to tackle multiple global challenges could be developed further without acute risk to human health, research suggests.

A revolutionary nanomaterial with huge potential to tackle multiple global challenges could be developed further without acute risk to human health, research suggests.

Carefully controlled inhalation of a specific type of graphene – the world’s thinnest, super strong, and super flexible material – has no short-term adverse effects on lung or cardiovascular function, the study shows.

Clinical Trial Insights

The first controlled exposure clinical trial in people was carried out using thin, ultra-pure graphene oxide – a water-compatible form of the material.

Researchers say further work is needed to find out whether higher doses of this graphene oxide material or other forms of graphene would have a different effect.

The team is also keen to establish whether longer exposure to the material, which is thousands of times thinner than a human hair, would carry additional health risks.

There has been a surge of interest in developing graphene – a material first isolated by scientists in 2004 and which has been hailed as a ‘wonder’ material. Possible applications include electronics, phone screens, clothing, paints, and water purification.

Graphene is actively being explored around the world to assist with targeted therapeutics against cancer and other health conditions, and also in the form of implantable devices and sensors. Before medical use, however, all nanomaterials need to be tested for any potential adverse effects.

Study Methodology and Findings

Researchers from the Universities of Edinburgh and Manchester recruited 14 volunteers to take part in the study under carefully controlled exposure and clinical monitoring conditions.

The volunteers breathed the material through a face mask for two hours while cycling in a purpose-designed mobile exposure chamber brought to Edinburgh from the National Public Health Institute in the Netherlands.

Effects on lung function, blood pressure, blood clotting, and inflammation in the blood were measured – before the exposure and at two-hour intervals. A few weeks later, the volunteers were asked to return to the clinic for repeated controlled exposures to a different size of graphene oxide, or clean air for comparison.

There were no adverse effects on lung function, blood pressure, or the majority of other biological parameters looked at.

Researchers noticed a slight suggestion that inhalation of the material may influence the way the blood clots, but they stressed this effect was very small.

Conclusions and Future Directions

Dr. Mark Miller, of the University of Edinburgh’s Centre for Cardiovascular Science, said: “Nanomaterials such as graphene hold such great promise, but we must ensure they are manufactured in a way that is safe before they can be used more widely in our lives.

“Being able to explore the safety of this unique material in human volunteers is a huge step forward in our understanding of how graphene could affect the body. With careful design, we can safely make the most of nanotechnology.”

Professor Kostas Kostarelos, of the University of Manchester and the Catalan Institute of Nanoscience and Nanotechnology (ICN2) in Barcelona, said: “This is the first-ever controlled study involving healthy people to demonstrate that very pure forms of graphene oxide – of a specific size distribution and surface character – can be further developed in a way that would minimize the risk to human health.

“It has taken us more than 10 years to develop the knowledge to carry out this research, from a materials and biological science point of view, but also from the clinical capacity to carry out such controlled studies safely by assembling some of the world’s leading experts in this field.”

Professor Bryan Williams, Chief Scientific and Medical Officer at the British Heart Foundation, said: “The discovery that this type of graphene can be developed safely, with minimal short-term side effects, could open the door to the development of new devices, treatment innovations and monitoring techniques.

“We look forward to seeing larger studies over a longer timeframe to better understand how we can safely use nanomaterials like graphene to make leaps in delivering lifesaving drugs to patients.”

Reference: “First-in-human controlled inhalation of thin graphene oxide nanosheets to study acute cardiorespiratory responses” by Jack P. M. Andrews, Shruti S. Joshi, Evangelos Tzolos, Maaz B. Syed, Hayley Cuthbert, Livia E. Crica, Neus Lozano, Emmanuel Okwelogu, Jennifer B. Raftis, Lorraine Bruce, Craig A. Poland, Rodger Duffin, Paul H. B. Fokkens, A. John F. Boere, Daan L. A. C. Leseman, Ian L. Megson, Phil D. Whitfield, Kerstin Ziegler, Seshu Tammireddy, Marilena Hadjidemetriou, Cyrill Bussy, Flemming R. Cassee, David E. Newby, Kostas Kostarelos and Mark R. Miller, 16 February 2024, Nature Nanotechnology.
DOI: 10.1038/s41565-023-01572-3

It was funded by the British Heart Foundation and the UKRI EPSRC.



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Ocular surface disease (OSD) is a term that encompasses a range of eye conditions, including dry eye syndrome (DES), conjunctivitis, and keratitis. It is estimated that nearly 40% of patients seen by eye care professionals are affected by OSD, posing a daily challenge for accurate diagnosis and treatment. This complexity stems from the multiple factors involved in the diagnosis and treatment of OSD, particularly DES, and the continuous advancements in OSD diagnostics and therapeutics.

Diagnostic Evaluations for OSD

Diagnostic evaluations for OSD typically include external and slit lamp examinations. There is a preference for utilizing neutral density filters and broad beam illumination, and the preferred diagnostic signs include lid margin evaluation, meibomian gland assessment, vital dye-assisted corneal staining, tear breakup time measurement, and tear meniscus size measurement. Biomarkers such as MMP-9, lactoferrin, and IgE are less commonly used.

Eye Care Professionals (ECPs) also utilize dry eye questionnaires for screening and monitoring symptom improvement, with DES being divided into evaporative, aqueous deficient, and combined mechanism categories.

Treatment Options

Treatment for level 1 DES includes artificial tears and lid hygiene. However, levels 2 to 4 may require additional therapies such as topical steroids, immunosuppressant eye drops, and office-based procedures. Surgical procedures, including intravitreal injections, are associated with DES and require preoperative diagnosis, intraoperative surface protection, and postoperative rehabilitation. Long-term care for surgical-associated DES is essential to managing the disease effectively.

Innovation in Dry Eye Treatment

In the last year, significant advancements in dry eye treatment have been noted. The approval of Xdemvy for the management of Demodex blepharitis, a common comorbidity seen in almost 70% of dry eye disease patients, stands out. This medication has demonstrated long-term efficacy, durability, and safety in improving the symptoms of Demodex blepharitis. In addition, Miebo, a prescription for the management of evaporative dry eye disease, has been shown to stabilize the tear film and improve meibum secretions, providing noticeable results within weeks of therapy.

Challenges in Diagnosis and Management

Despite these advancements, several challenges remain in the diagnosis and management of OSD, particularly in low and middle-income countries. Infectious eye diseases contribute significantly to global visual impairment and blindness. The need for separate prevalence studies for ocular infections is emphasized because they frequently affect younger people.

Understanding the geographic distribution and modes of transmission of infectious eye diseases, as well as the potential impacts of global warming, conflict, food poverty, urbanization, and environmental degradation on their prevalence, is crucial. The need for enhanced global reporting networks and artificial intelligence systems for disease surveillance and monitoring is also highlighted.

Looking Forward: Clinical Trials and Future Research

Further research is being conducted to develop more effective treatments for OSD. A recent Phase 3 trial of SYL10111_V (tivanisiran) sponsored by PharmaMar subsidiary Sylentis, aimed to evaluate the signs and symptoms of dry eye disease caused by Sjögren syndrome. Although the trial did not meet its primary endpoint, it contributes valuable information to the ongoing effort to improve the management of OSD.

In conclusion, the diagnosis and treatment of OSD are dynamic and challenging fields. While there have been significant advancements, much work remains to be done. Continued research, innovation, and a commitment to long-term care and maintenance therapy are essential to improving outcomes for patients with OSD.

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New Delhi, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Global mechanical ventilator market was valued at US$ 4,772.8 million in 2023 and is estimated to generate a revenue of US$ 9,668.8 million by 2032 at a CAGR of 8.16% during the forecast period.

Over the past four years, the mechanical ventilator market has experienced some significant bumps. It’s been on a roller coaster ride of demand since 2019. The global health landscape and technological advancements in healthcare have played major roles in these changes. At first, the spread of COVID-19 led to an unprecedented need for mechanical ventilators. Clearly, that illness is no stranger to respiratory issues, so having a device that focuses entirely on managing severe respiratory conditions was essential. Even though we’re now starting to see a decrease in cases worldwide, the demand for ventilators has not gone back down to what it was pre-pandemic.

Astute Analytica predicts that aging population will cause chronic respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) and asthma to become more common. In 2023 alone, 4 million people died from CRDs across the globe. There were also nearly 483 million cases reported worldwide within that same year. Although there’s been an increase of 28.5% in total deaths caused by CRDs between 1990 and 2019 and an increase of 39.8% in prevalence over that same span of time, rates adjusted for age have actually gone down. Preventive measures must be taken in order to curb these numbers even further — and fast — before they start skyrocketing again.

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The race for technological advancement is always present and can be found within every single industry known to humanity — including healthcare! Since Covid-19 pandemic, more hospitals now prefer non-invasive ventilation systems over invasive ones because they’re less problematic for patients and decrease the risk of infection associated with invasive mechanical ventilation. After all, they’ve already gone through enough pain and suffering in order to have ended up on a hospital bed — they don’t need any more added on top of it. Home healthcare settings are also contributing significantly to the global mechanical ventilator market. Additionally, the healthcare industry's focus is expanding beyond hospitals to include home healthcare settings, where patients benefit from the availability of portable and user-friendly ventilators.

Market Forecast (2032) US$ 9,668.8 Million
CAGR 8.16%
By Component Hardware/Devices (90.2%)
By Type Positive Pressure Ventilation (63%)
By Mode Non-Invasive (57%)
By Mobility Fixed (57%)
By End Users Hospitals (45%)
By Age Group Adult (43%)
Top Trends
  • Increasing portable ventilator adoption
  • Rise in telehealth integration
  • Enhanced focus on multipurpose ventilators
Top Drivers
  • Growing respiratory disease prevalence
  • Aging global population
  • Technological advancements
Top Challenges
  • High product costs
  • Lack of skilled professionals
  • Stringent regulatory standards

Portable Mechanical Ventilators to Witness Growth in Demand at Highest CAGR of 8.39%

The global portable mechanical ventilator market is witnessing rapid growth, and this trend is likely to continue in the near future. The primary reason behind this increase in demand for portable mechanical ventilators is the rise in demand for mobile healthcare services and the need for respiratory support outside traditional hospital settings. Mainly due to their ability to offer breathing assistance to patients who require help but are not confined to stationary, hospital-based units. They provide flexibility, mobility, and high-end respiratory condition management tools that make them popular among healthcare providers. Moreover, as advancements in technology lead to smaller, lighter devices with higher efficiency rates it enables better patient mobility and comfort. Smaller size also means a boost in quality of life for patients who require these devices.

Some prominent portable mechanical ventilators witnessing strong influx of demand:

  • Philips Respironics Trilogy: A device known for its versatility which offers both invasive and non-invasive ventilatory support. It's designed for home and mobile use catering adult pediatric patients.
  • Hamilton Medical's HAMILTON-T1: Designed specifically for transport & emergency usage by combining everything you'd find on a fully equipped intensive care unit ventilator into a convenient transportable size.
  • Ventec Life Systems' VOCSN: This device combines five separate machines such as an oxygen concentrator, nebulizer,suction cough assist, and much more into one single portable unit optimizing patient mobility.
  • ResMed Astral: Offers lightweight options along with long battery life life-supporting invasive/non-invasive ventilation options.

US is the Largest Consumer of Mechanical Ventilators

US stands as the largest user of mechanical ventilator market globally, reflecting its advanced healthcare infrastructure and its contribution to over 80% of the mechanical ventilator demand in North America. The dominance can be attributed to multiple factors including total demand of mechanical ventilators, burden of respiratory diseases, financial investments in healthcare technology, availability of ventilators in hospitals, regulatory frameworks, market trends and key industry players. U.S. had an age standardized rate of IMV usage 618 patients which is four times higher than England’s rate and two times higher than Canada’s rate.

Demand for mechanical ventilators in U.S. is driven by a high disease burden including chronic obstructive pulmonary disease (COPD), asthma and most recently from the impact of respiratory infections like COVID-19. The country's large population suffering from these conditions necessitates a robust supply.
Regarding diagnoses at hospitalization, acute myocardial infarction was more common in the U.S. cohort (150 per 1,000 hospitalizations) vs. England and Canada (each 40 per 1,000 hospitalizations). However reports suggest that billions have been invested to ensure availability and accessibility within the U.S., with some devices priced into millions each.

The number of mechanical ventilation devices available across hospitals in U.S. mechanical ventilator market, vary largely influenced by hospital size, location and patient population served: large hospitals based in urban areas may have hundreds while smaller rural facilities could have less than five — highlighting disparities in healthcare access despite overall high availability. Mechanical ventilators are regulated by FDA to ensure safety standards before they're used on patients — this has become especially important during COVID-19 pandemic where rapid acquisition efforts led FDA to issue emergency use authorizations for new devices without rigorous premarket review process commonly required. As for market dynamics, U.S. is moving toward development of more sophisticated, patient-friendly ventilators that incorporate AI to improve patient outcomes and operational efficiencies. This means companies will continually innovate and compete to provide systems. Major players including Medtronic, Philips Healthcare and GE Healthcare have contributed significantly in supplying mechanical ventilators not only in domestic market but also globally — a testament underscoring the country's central role in respiratory care technology sector.

Top 6 Players in Global Mechanical ventilator market Captures Over 78% Revenue Share

Medtronic, Koninklijke Philips N.V., Mindray Medical International Limited, Drägerwerk AG & Co. KGaA, Getinge AB, and Hamilton Medical are top 6 players in the market. Wherein, Getinge AB is leading the pact with highest market share of 21% in 2023.

As per Astute Analytica, Getinge AB and Hamilton Medical are leading the global mechanical ventilator market, with Getinge AB being the most prominent. The two companies have amassed a significant portion of the share of revenue in this sector. Their success is due to unyielding innovation, strategic positioning, and complete product portfolios that serve health systems worldwide who grow with markets. Getinge AB is a Swedish company that has a rich history in medical technology. They secured their leadership through extensive R&D to create technologically advanced and user-friendly ventilators. Healthcare workers know them for their reliability, precision, and adaptability across various clinical settings. They can be used in intensive care units as well as emergency rooms.

Their reputation is cemented by their reliability to provide quality products and patient safety assurance. Combine that with their global reach and top-tier customer service, healthcare providers trust them.

Hamilton Medical operates from Switzerland, but still manages to capture a substantial number of sales in the global mechanical ventilator market or any other one they operate in. They work hard to design ventilators that enhance patient comfort and improve outcomes, all while making clinical processes simple for both caretaker and decision-making.

The software on these devices are so advanced that they can mimic lung protective strategies for customized care. Both companies also offer the same services such as distribution networks across the globe, high-profile collaborations with healthcare institutions, active participation in clinical studies.

Recent Developments Shaping the Global Mechanical ventilator market

  • In September 2023, a patent was awarded to engineers at Villanova for the NovaVent Mechanical Ventilator, a cost-effective solution.
  • Draeger Medical, Inc. issued a recall for its Carina Ventilators in August 2023 because of contaminants found in the device's airpath. These contaminants are at levels considered unacceptable for pediatric patients using the device for over 30 days. This recall has been classified as Class I by the Food and Drug Administration, indicating a serious risk of injury or death.
  • The FDA approved the Servo-air Lite, a gas-independent, non-invasive mechanical ventilator by Getinge, in July 2023.
  • Also in July 2023, Portsmouth Aviation revealed its innovative negative pressure ventilator system, which is set to proceed to production and clinical trials.

Top Players in the Global Mechanical Ventilator Market:

  • Becton, Dickinson and Company
  • Bunnell Incorporated
  • Carl Reiner GmbH
  • Drägerwerk AG & Co. KGaA
  • GE Healthcare
  • Getinge AB
  • Hamilton Medical
  • ICU Medical, Inc
  • Koninklijke Philips N.V.
  • Medtronic
  • Mindray Medical International Limited
  • Penlon Limited
  • ResMed
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd
  • Smiths Medical
  • Vyaire Medical Inc.
  • Zoll Medical Corporation
  • Other prominent players

Astute Analytica has segmented Global Mechanical Ventilator Market report based on Component, Type, Mode, Mobility, Age Group, End User and Region

By Component

  • Hardware/Devices,
  • Services

By Type

  • Negative pressure ventilation (NPV),
  • Positive pressure ventilation (PPV)

By Mode

  • Invasive
  • Non-invasive
  • CPAP
  • BiPAP
  • Others

By Mobility

By Age Group

  • Pediatric & Neonatal,
  • Adult, Geriatric

By End User

  • Hospital & Clinic,
  • Home Care,
  • Ambulatory Surgical Center
  • Others

By Region Outlook

  • North America (U.S., Canada, Mexico)
  • Europe (Western Europe [The UK, France, Germany, Italy, Spain Rest of Western Europe], Eastern Europe [Poland, Russia, Rest of Europe])
  • Asia Pacific (Japan, China, India, Australia & New Zealand, ASEAN, Rest of Asia pacific)
  • South America (Brazil, Argentina, Rest of South America)
  • Middle East (UAE, Saudi Arabia, Egypt, Rest of Middle East)
  • Africa (South Africa, Nigeria, Rest of Africa)

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About Astute Analytica

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The Promise of Lung Stem Cell Transplants for COPD

Chronic obstructive pulmonary disease (COPD) is a critical health concern worldwide. According to a featured report in the latest issue of Science Translational Medicine, lung stem cell transplants are showing promise in early clinical trials for the treatment of this disease. This development is particularly significant considering the increasing prevalence of COPD and the projected rise in related mortality.

Research into the potential of extracellular vesicles (EVs) in COPD treatment is also yielding promising results. EVs play an essential role in maintaining pulmonary homeostasis and protecting the respiratory tract from environmental pathogens. Their potential clinical value could revolutionize the way we approach COPD treatment.

Adoptive T Cells: A New Hope for Refractory Multiple Myeloma

The same issue of Science Translational Medicine also features a study on adoptive T cells. This new generation of T cells shows promise in treating refractory multiple myeloma in experimental mice models. This is a significant step forward, as treatment options for multiple myeloma continue to evolve rapidly, and novel therapies are desperately needed.

Consolidation Durvalumab Therapy for Stage III NSCLC Patients

Further advancements in lung cancer treatment have also been reported. A study on consolidation durvalumab therapy for patients with unresectable stage III non-small cell lung cancer (NSCLC) showed comparable outcomes for older and younger patients. This is a significant finding, particularly as the median age of the study’s participants was 67 years.

The study showed a 2-year overall survival (OS) rate of 65.2% in patients aged 70 years and older, compared to 74.8% in the younger cohort. The research found that factors such as older age, a Charlson Comorbidity Index (CCI) score of 5 or higher, and EGFR mutations were associated with OS.

The study also found potential links between EGFR mutations, previous tobacco use, and worse progression-free survival among older patients. Adverse events during consolidation durvalumab were observed in 77% of patients, with 14.5% being grade 3 or 4. Interestingly, the study suggested that a patient’s comorbidity burden, rather than their age, might have a more significant influence on their ability to tolerate durvalumab treatment. This insight emphasizes the need for a more detailed assessment of older patients to determine the most appropriate treatment.

Translational Medicine: The Future is Here

The recent findings reported in Science Translational Medicine underscore the incredible progress being made in the field of translational medicine. From lung stem cell transplants to adoptive T cells, researchers are exploring new frontiers in medical treatment. These developments hold significant promise for a future where diseases like COPD and multiple myeloma can be effectively managed or even cured.

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