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

Nurse Clinical Trial

— Masq-Aute  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427176
• Other study ID #: 20CH073
• Secondary ID: 2020-A00817-32
• Status: Completed
• Start date: April 29, 2020
• Est. completion date: May 28, 2020

Study information

• Verified date: June 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nurse

Intervention

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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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