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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).

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04427176
Acronym
Masq-Aute
Enrollment
15
Registered
2020-06-11
Start date
2020-04-29
Completion date
2020-05-28
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nurse

Keywords

mask, ARFC, Covid-19, protection

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.

Interventions

DEVICEARFC 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of toleranceHour: 48Tolerance 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.
Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures.Hour: 48Compatibility 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.

Secondary

MeasureTime frameDescription
Assess the acceptability of the wearing of an ARFC mask by nursing staffHours: 0, 48To compare acceptability questionnaires complete at inclusion and 48 jours after.
To assess the minor complications of wearing the ARFC mask .Hour: 48Occurrence 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.).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026