An interventional study of surgical mask (5 different types) in Chronic Obstructive Pulmonary Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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")
Time frame: immediately after a rehabilitation session
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")
Time frame: 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")
Time frame: 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).
Time frame: 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").
Time frame: 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.
Time frame: immediately after a rehabilitation session
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Assistance Publique - Hôpitaux de Paris