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

NCT ID: NCT04427176

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-29

Study Completion Date

2020-05-28

Brief Summary

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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.

Detailed Description

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Conditions

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Nurse

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ARFC mask

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc PERROT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2020-A00817-32

Identifier Type: OTHER

Identifier Source: secondary_id

20CH073

Identifier Type: -

Identifier Source: org_study_id

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