Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).

Study Overview
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Brief Summary
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The current outbreak of Covid-19 requires the wearing of FFP2 respiratory protective devices by healthcare personnel to limit their contamination. However, there is currently a shortage of masks in France due to insufficient national stocks while the disease is spreading. There is an urgent need to save FFP2 masks to enable healthcare personnel to continue to provide care in complete safety. Contamination of staff due to insufficient masks would have consequences by limiting access to care for infected patients and putting caregivers at potential risk of death. Caregiver protection is also intended to contain the risk of nosocomial epidemics. We propose the use of ARFC masks by Covid-19+ units. These ARFC masks provide optimal security against the risk of aerosolization of contaminated biological liquids. They are masks modified to be usable by civilians, resulting from the technology of combat masks, specially designed for use in NRBC (Nuclear, Radiological, Biological and Chemical) atmosphere.

Official Title
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Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).

Conditions
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Nurse

Intervention / Treatment
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* Device: ARFC mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nursing staff working 8 or 12 hours a day for 2 consecutive days in a COVID unit at the hospital of Saint Etienne. Subjects affiliated to or entitled to a social security scheme Subject who received informed information about the study and agreed to participate in the study Exclusion Criteria: Allergy to ARCF mask material: polyurethane Impossibility of supporting a tight mask on the face Potential contraindication to wearing a mask, such as the existence of claustrophobia Beard and moustache wearer Suspicion of COVID-19 infection Refusal to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nurses<br>Nursing staff working 8 or 12 hours a day for 2 consecutive days in a COVID unit at the hospital of Saint Etienne will be included. They will be wear ARFC mask. | Device: ARFC mask<br>* Nurse will wear the ARFC mask during working days. The total duration of the study will be 48 hours for each participant, 2 consecutive working days of 8 or 12 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance | Tolerance will be assessed by the nursing staff by means of a visual analogue scale from 0: no tolerance to 10: perfect tolerance. It will be evaluated 48 hours after the inclusion. | Hour: 48 | 
| Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures. | Compatibility will be assessed by the number of catheter insertion and blood sampling failures in relation to the total number of catheter insertions and blood sampling indicated at 48 hours after the inclusion. | Hour: 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the acceptability of the wearing of an ARFC mask by nursing staff | To compare acceptability questionnaires complete at inclusion and 48 jours after. | Hours: 0, 48 | 
| To assess the minor complications of wearing the ARFC mask . | Occurrence of minor complications related to the wearing of the mask as reported for non-invasive ventilation (dry mouth, nose, conjunctivitis, skin lesions at the support point, etc.). | Hour: 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mask, ARFC, Covid-19, protection