Tolerance of Surgical Masks in Chronic Respiratory Diseases

NCT ID: NCT05454631

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2023-10-30

Brief Summary

The study is conducted in the context of the COVID-19 pandemic in general, and more specifically in the context of the evaluation of the use of protective masks as a barrier to the spread of the virus. The wearing of masks is one of the recommended barrier measures to limit the spread of the SARS-CoV-2 virus responsible for COVID-19. It is recommended in all circumstances, and mandatory in some. Regardless of the type of mask used (noting that the so-called "surgical" masks are by far the most common), there are various disadvantages associated with wearing them. Dyspnoea (unpleasant or upsetting perception of respiratory activity) is one of these disadvantages. It can lead to reluctance to wear the mask, or to the adoption of inappropriate practices that reduce its effectiveness. This "side effect" of the mask is more pronounced in patients with underlying respiratory diseases. However, not all mask designs are equivalent in terms of their physical properties, which can theoretically generate varying levels of dyspnoea. It is therefore important to determine which mask designs are more or less dyspnogenic, in order to guide the preferential use of certain designs in certain patient categories. The TOLMASK study (Tolerance of SARS-CoV2 Surgical Masks in Patients with Chronic Respiratory Diseases) is a prospective, randomised, triple-blind, single-centre study comparing several surgical masks in a crossover design. The primary objective of the study is to evaluate the respiratory tolerance of different surgical masks and the secondary objective is to evaluate their general tolerance.

Detailed Description

The study was conducted in the context of the COVID-19 pandemic in general, and more specifically in the context of the evaluation of the use of protective masks as a barrier to the spread of the virus. The wearing of masks is one of the recommended barrier measures to limit the spread of the SARS-CoV-2 virus responsible for COVID-19. It is recommended in all circumstances, and mandatory in some. Regardless of the type of mask used (noting that the so-called "surgical" masks are by far the most common), there are various disadvantages associated with wearing them. Dyspnoea (unpleasant or worrying perception of respiratory activity) is one of these disadvantages. It can lead to reluctance to wear the mask, or to the adoption of inappropriate practices that reduce its effectiveness. This "side effect" of the mask is more pronounced in patients with underlying respiratory diseases. However, not all mask designs are equivalent in terms of their physical properties, which can theoretically generate varying levels of dyspnoea. It is therefore important to determine which mask designs are more or less dyspnogenic, in order to guide the preferential use of certain designs in certain patient categories. The TOLMASK study (Tolerance of SARS-CoV2 Surgical Masks in Patients with Chronic Respiratory Diseases) is a prospective, randomised, triple-blind, single-centre study comparing several surgical masks in a crossover design. The primary objective of the study is to evaluate the respiratory tolerance of different surgical masks and the secondary objective is to evaluate their general tolerance.

The inclusion criteria are : 1) patient hospitalised in the respiratory and neuro-respiratory rehabilitation department of the R3S department at the Pitié-Salpêtrière Hospital (Pr Gonzalez-Bermejo); 2) patient enrolled in a respiratory rehabilitation process including exercise training on a cyclo-ergometer or treadmill; 3) hospitalisation in the respiratory rehabilitation department either post-exacerbation of COPD (usual recruitment of the department) or post-COVID (depending on the epidemic situation at the time of the study); 4) patient of age.

The criteria for non-inclusion are 1) Exercise re-training under mask ventilatory assistance; 2) Presence of a tracheotomy; 3) Psychiatric disorders (at the discretion of the referring physician); 4) Insufficient command of the French language; 5) Refusal to participate in the study.

50 patients will be included, over a period of 4 months. The duration of participation is 5 days.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

patient present at the respiratory SSR department of the Pitié-Salpêtrière hospital

All the participants will evaluate 5 different types of surgical mask, in random order.

Group Type: EXPERIMENTAL

surgical mask (5 different types)

Intervention Type: DEVICE

All the participants will wear 5 different types of surgical mask, in random order.

Interventions

surgical mask (5 different types)

All the participants will wear 5 different types of surgical mask, in random order.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas SIMILOWSKI, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Département R3S, Hôpital Pitié-Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas SIMILOWSKI, MD

Role: CONTACT

thomas.similowski@aphp.fr

+33 (0) 6 69 76 72 52

Antoine GUERDER, MD

Role: CONTACT

antoine.guerder@aphp.fr

‭+33 (0) 6 09 04 59 11‬

Facility Contacts

Thomas Siliwoski, MD,PhD

Role: primary

thomas.similowski@aphp.fr

0669767252 ext. +33

References

Serresse L, Simon-Tillaux N, Decavele M, Gay F, Nion N, Lavault S, Guerder A, Chatelet A, Dabi F, Demoule A, Morelot-Panzini C, Moricot C, Similowski T. Lifting dyspnoea invisibility: COVID-19 face masks, the experience of breathing discomfort, and improved lung health perception - a French nationwide survey. Eur Respir J. 2022 Mar 31;59(3):2101459. doi: 10.1183/13993003.01459-2021. Print 2022 Mar.

Reference Type: BACKGROUND

PMID: 34475232 (View on PubMed)

Other Identifiers

APHP220201

Identifier Type: -

Identifier Source: org_study_id