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

NCT04427176 | Completed

• 2 other identifiers: 20CH0732020-A00817-32
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse

Keywords

mask; ARFC; Covid-19; protection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Assess the acceptability of the wearing of an ARFC mask by nursing staff

  Hours: 0, 48

• To assess the minor complications of wearing the ARFC mask .

  Hour: 48

Study Arms (1)

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

Interventions

ARFC mask DEVICE

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.

Nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Luc PERROT, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 11, 2020
• Study Start: April 29, 2020
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)