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

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.

Study Overview

• Status: Completed
• Conditions: Nurse
• Intervention / Treatment: Device: ARFC mask

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nurses; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Jean-Luc PERROT, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Covid-19; mask; protection; ARFC
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20CH073; 2020-A00817-32 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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