Clinical trial NCT04427176: Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).
Official title: Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nurse
Keywords: mask
ARFC
Covid-19
protection
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing staff working 8 or 12 hours a day for 2 consecutive days in a COVID unit at the hospital of Saint Etienne.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance
timeFrame: Hour: 48
measure: Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures.
timeFrame: Hour: 48
Secondary outcomes:
measure: Assess the acceptability of the wearing of an ARFC mask by nursing staff
timeFrame: Hours: 0, 48
measure: To assess the minor complications of wearing the ARFC mask .
timeFrame: Hour: 48
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Luc PERROT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: