Tolerance of Surgical Masks in Chronic Respiratory Diseases

Chronic Obstructive Pulmonary Disease Clinical Trial

— TOLMASK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454631
• Other study ID #: APHP220201
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Thomas SIMILOWSKI, MD
• Phone: +33 (0) 6 69 76 72 52
• Email: thomas.similowski[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Device:
• surgical mask (5 different types)
All the participants will wear 5 different types of surgical mask, in random order.

Locations

Country	Name	City	State
France	Département R3S, Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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