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OpenTrials
Completed

NCT Number: NCT04427176

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

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.

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Key information

Conditions

Nurse COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance

    Time frame: Hour: 48

    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.

  2. Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures.

    Time frame: Hour: 48

    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.

Secondary outcomes

  1. Assess the acceptability of the wearing of an ARFC mask by nursing staff

    Time frame: Hours: 0, 48

    To compare acceptability questionnaires complete at inclusion and 48 jours after.

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

    Time frame: Hour: 48

    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.).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: Masq-Aute

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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