<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04427176</url>
  </required_header>
  <id_info>
    <org_study_id>20CH073</org_study_id>
    <secondary_id>2020-A00817-32</secondary_id>
    <nct_id>NCT04427176</nct_id>
  </id_info>
  <brief_title>Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).</brief_title>
  <acronym>Masq-Aute</acronym>
  <official_title>Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current outbreak of Covid-19 requires the wearing of FFP2 respiratory protective devices&#xD;
      by healthcare personnel to limit their contamination.&#xD;
&#xD;
      However, there is currently a shortage of masks in France due to insufficient national stocks&#xD;
      while the disease is spreading.&#xD;
&#xD;
      There is an urgent need to save FFP2 masks to enable healthcare personnel to continue to&#xD;
      provide care in complete safety. Contamination of staff due to insufficient masks would have&#xD;
      consequences by limiting access to care for infected patients and putting caregivers at&#xD;
      potential risk of death. Caregiver protection is also intended to contain the risk of&#xD;
      nosocomial epidemics. We propose the use of ARFC masks by Covid-19+ units. These ARFC masks&#xD;
      provide optimal security against the risk of aerosolization of contaminated biological&#xD;
      liquids. They are masks modified to be usable by civilians, resulting from the technology of&#xD;
      combat masks, specially designed for use in NRBC (Nuclear, Radiological, Biological and&#xD;
      Chemical) atmosphere.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 29, 2020</start_date>
  <completion_date type="Actual">May 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 28, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance</measure>
    <time_frame>Hour: 48</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures.</measure>
    <time_frame>Hour: 48</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the acceptability of the wearing of an ARFC mask by nursing staff</measure>
    <time_frame>Hours: 0, 48</time_frame>
    <description>To compare acceptability questionnaires complete at inclusion and 48 jours after.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the minor complications of wearing the ARFC mask .</measure>
    <time_frame>Hour: 48</time_frame>
    <description>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.).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Nurse</condition>
  <arm_group>
    <arm_group_label>Nurses</arm_group_label>
    <description>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.&#xD;
They will be wear ARFC mask.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ARFC mask</intervention_name>
    <description>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.</description>
    <arm_group_label>Nurses</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Nursing staff working 8 or 12 hours a day for 2 consecutive days in a COVID unit at the&#xD;
        hospital of Saint Etienne.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nursing staff working 8 or 12 hours a day for 2 consecutive days in a COVID unit at&#xD;
             the hospital of Saint Etienne.&#xD;
&#xD;
          -  Subjects affiliated to or entitled to a social security scheme&#xD;
&#xD;
          -  Subject who received informed information about the study and agreed to participate in&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to ARCF mask material: polyurethane&#xD;
&#xD;
          -  Impossibility of supporting a tight mask on the face&#xD;
&#xD;
          -  Potential contraindication to wearing a mask, such as the existence of claustrophobia&#xD;
&#xD;
          -  Beard and moustache wearer&#xD;
&#xD;
          -  Suspicion of COVID-19 infection&#xD;
&#xD;
          -  Refusal to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Luc PERROT, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mask</keyword>
  <keyword>ARFC</keyword>
  <keyword>Covid-19</keyword>
  <keyword>protection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427176
org study id: 20CH073
secondary id: 2020-A00817-32
nct id: NCT04427176
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Prospective
measure: Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance
time frame: Hour: 48
description: 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.
measure: Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures.
time frame: Hour: 48
description: 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.
measure: Assess the acceptability of the wearing of an ARFC mask by nursing staff
time frame: Hours: 0, 48
description: To compare acceptability questionnaires complete at inclusion and 48 jours after.
measure: To assess the minor complications of wearing the ARFC mask .
time frame: Hour: 48
description: 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.).
arm group label: Nurses
description: 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.
intervention type: Device
intervention name: ARFC mask
description: 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.
arm group label: Nurses
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Luc PERROT, MD PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No