Tolerance of Surgical Masks in Chronic Respiratory Diseases (TOLMASK)

Satisfaction Survey on the Tolerability of Surgical Masks for Protection Against the Spread of SARS-CoV2 in Patients With Chronic Respiratory Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: surgical mask (5 different types)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas SIMILOWSKI, MD; Phone Number: +33 (0) 6 69 76 72 52; Email: thomas.similowski@aphp.fr
• Study Contact Backup: Name: Antoine GUERDER, MD; Phone Number: ‭+33 (0) 6 09 04 59 11‬; Email: antoine.guerder@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Département R3S, Hôpital Pitié-Salpêtrière
    • Contact: Thomas Siliwoski, MD,PhD; Phone Number: +33 0669767252; Email: thomas.similowski@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: surgical mask (5 different types); All the participants will wear 5 different types of surgical mask, in random order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensory 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
relief	Intensity of relief on mask removal, rated on an 11-point ordinal scale (from "0, mask removal caused no relief" to "10, mask removal caused absolute relief")	immediately after a rehabilitation session
MDP (Multidimensional Dyspnea Profile)	Response to the Multidimensional Dyspnea Profile questionnaire (French version) The Multidimensional Dyspnoea Profile (MDP) consists of eleven 0-10 numerical rating scales describing the unpleasantness of dyspnea (A1, maximum score of 10), its sensory qualities (5 items [SQ], maximum 50), and its emotional qualities (5 items [A2], maximum 50).	immediately after a rehabilitation session
general comfort	Overall comfort of the mask tested, rated on an 11-point ordinal scale (from "0, this mask is horribly uncomfortable", to "10, this mask is perfectly comfortable").	immediately after a rehabilitation session
choice	Overall comfort of the mask tested, rated on Choice and ranking of 5 mask disadvantages from a list of 15 In addition, at the end of the study, patients will be asked to indicate which of the masks tested they preferred.	immediately after a rehabilitation session

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Thomas SIMILOWSKI, MD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: COPD; COVID-19; pulmonary rehabilitation; breathlessness; face masks
• Additional Relevant MeSH Terms: Pathologic Processes; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: APHP220201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No