Tolerance of Surgical Masks in Chronic Respiratory Diseases

NCT05454631 | Unknown

• 1 other identifier: APHP220201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

breathlessness; face masks; COVID-19; COPD; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• affective dimension of dyspnea

  Intensity of the sensory dimension of respiratory discomfort attributed to wearing the mask during exercise training, assessed on an 11-point ordinal scale (from "0, the mask caused no particular respiratory sensation" to "10, the mask caused a respiratory sensation as intense as I can imagine")

  immediately after a rehabilitation session

Secondary Outcomes (5)

• sensory dimension of dyspnea

  immediately after a rehabilitation session

• relief

  immediately after a rehabilitation session

• MDP (Multidimensional Dyspnea Profile)

  immediately after a rehabilitation session

• general comfort

  immediately after a rehabilitation session

• choice

  immediately after a rehabilitation session

Study Arms (1)

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

EXPERIMENTAL

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

Device: surgical mask (5 different types)

Interventions

surgical mask (5 different types) DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Département R3S, Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 34475232 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Thomas SIMILOWSKI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas SIMILOWSKI, MD

CONTACT

+33 (0) 6 69 76 72 52; thomas.similowski@aphp.fr

Antoine GUERDER, MD

CONTACT

‭+33 (0) 6 09 04 59 11‬; antoine.guerder@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: not everyone involved in the research (patients, investigators, caregivers, and statistical analysis stakeholders) will know which mask the patient is using at which time.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: February 6, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

FR (1)