Evaluating the comfort of different surgical masks for patients with chronic respiratory diseases
Satisfaction Survey on the Tolerability of Surgical Masks for Protection Against the Spread of SARS-CoV2 in Patients With Chronic Respiratory Diseases
This study is testing which types of surgical masks are the most comfortable for patients with chronic respiratory diseases to wear, especially during the COVID-19 pandemic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05454631 on ClinicalTrials.gov |
What this trial studies
This study investigates the tolerance of various surgical masks among patients with chronic respiratory diseases, particularly in the context of the COVID-19 pandemic. It aims to identify which mask designs cause less discomfort, specifically dyspnoea, during use. The study employs a prospective, randomised, triple-blind, single-centre crossover design, comparing five different types of surgical masks. Participants will be patients undergoing respiratory rehabilitation at a specific hospital, and the findings could help guide mask recommendations for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are hospitalized for respiratory rehabilitation due to chronic obstructive pulmonary disease.
Not a fit: Patients who are on mask ventilation support or have a tracheostomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mask tolerance for patients with chronic respiratory diseases, enhancing their safety and comfort during the pandemic.
How similar studies have performed: While studies on mask tolerance exist, this specific approach focusing on chronic respiratory disease patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient hospitalised in the respiratory and neuro-respiratory SSR service of the R3S department at the Pitié-Salpêtrière Hospital (Pr Gonzalez-Bermejo) * Patient enrolled in a respiratory rehabilitation process including exercise training on a cyclo-ergometer or treadmill * Hospitalization in respiratory rehabilitation unit either in post-exacerbation of COPD * age over 18 Exclusion Criteria: * Exercise training under mask ventilation support * Presence of a tracheostomy * Psychiatric disorders (at the discretion of the referring physician) * Insufficient command of the French language * Refusal to participate in the study
Where this trial is running
Paris
- Département R3S, Hôpital Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Thomas SIMILOWSKI, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Thomas SIMILOWSKI, MD
- Email: thomas.similowski@aphp.fr
- Phone: +33 (0) 6 69 76 72 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.