<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/NCT04416919</url>
  </required_header>
  <id_info>
    <org_study_id>11887</org_study_id>
    <nct_id>NCT04416919</nct_id>
  </id_info>
  <brief_title>Assessment of N-95 Facemask for Use in COVID-19 Pandemic in Case of Shortage of Personal Protective Equipment</brief_title>
  <official_title>A Proposed Alternative to the N-95 Mask Shortage in the COVID-19 Pandemic. A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oklahoma</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 purpose of this study is to assess the safety and efficiency of an assembled modified&#xD;
      mask in protecting health care workers against Coronavirus in case of any personal protective&#xD;
      equipment shortage. At least 20 healthy participants will be recruited to try the modified&#xD;
      mask. The modified masks will be made from masks that are already available as well as&#xD;
      filters available in the pulmonary department at the Oklahoma City VA Health Care System&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success Percentage</measure>
    <time_frame>15 minutes</time_frame>
    <description>Conduct a quantitative fit test and calculate the percentage of participants who pass the test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>End-tidal CO2 Variation. Description: mmHg.</measure>
    <time_frame>at 0 and 15 minutes</time_frame>
    <description>Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Pulse Oximetry Variation. Description: mmHg.</measure>
    <time_frame>at 0 and 15 minutes.</time_frame>
    <description>Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mask Visibility. Description: Likert Scale.</measure>
    <time_frame>15 minutes</time_frame>
    <description>Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness of usage. Description: Likert Scale.</measure>
    <time_frame>after 15 minutes</time_frame>
    <description>When the mask is removed, participants will be asked about willingness to use this mask compared to N-95 masks using a 5-point Likert scale from 'Very unlikely' to 'Very likely'.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Disease Prevention</condition>
  <arm_group>
    <arm_group_label>Assembled Mask</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participant will be fitted with a full-face mask that covers the mouth and nose or a Whole face mask that covers the eyes, nose, and mouth depending on participant's preferences. The Fitted Mask will be attached to a bacterial/viral filter for fit testing. After completing the Fit test, the mask will be placed on the face for 15 minutes while the participant performs various activities to document the ability to tolerate the respirator. Participants oxygen and carbon dioxide level will be measured in the beginning and at the end of the 15 minutes. The individuals will be able to remove the Mask anytime if they experience significant discomfort or claustrophobia. At the end, the mask will be removed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assembled mask</intervention_name>
    <description>Assembled masks consisting of 3 parts: A facemask (Respironics Performax Whole Face Mask or Hans Rudolph mask naso-oral mask) linked by a blue elbow ( RP Performax SE ELBOW) to a ventilator filter (Teleflex Bacterial/Viral filter 1605 or Iso-Gard HEPA light Filter 28022)</description>
    <arm_group_label>Assembled Mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. All individuals older than 18 years of age, and willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with known severe COPD/emphysema, Obesity Hypoventilation or hypercapnic&#xD;
             condition&#xD;
&#xD;
          2. Individuals with allergy or reactions to latex or masks&#xD;
&#xD;
          3. Individuals reporting dyspnea or unable to breathe comfortably in these masks&#xD;
&#xD;
          4. Claustrophobic individuals&#xD;
&#xD;
          5. Inability to create a proper Seal while inhaling through a closed filter (See Below)&#xD;
&#xD;
          6. Individuals who cannot safely apply and remove these masks&#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>Houssein Youness, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma HSC - OKC Veterans Affairs Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oklahoma City VA Health Care System</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Prevention CfDCa. Strategies for Optimizing the Supply of Facemasks: COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face-masks.html</citation>
  </reference>
  <results_reference>
    <citation>van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.</citation>
    <PMID>32182409</PMID>
  </results_reference>
  <results_reference>
    <citation>Qian Y, Willeke K, Grinshpun SA, Donnelly J, Coffey CC. Performance of N95 respirators: filtration efficiency for airborne microbial and inert particles. Am Ind Hyg Assoc J. 1998 Feb;59(2):128-32. doi: 10.1080/15428119891010389.</citation>
    <PMID>9487666</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>2019 novel coronavirus disease</keyword>
  <keyword>2019 novel coronavirus infection</keyword>
  <keyword>COVID-19 pandemic</keyword>
  <keyword>COVID-19 virus disease</keyword>
  <keyword>COVID19</keyword>
  <keyword>COVID-19 virus infection</keyword>
  <keyword>N-95</keyword>
  <keyword>Respiratory protective devices</keyword>
  <keyword>Protection from respiratory infecton</keyword>
  <keyword>Safety</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Pandemic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</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/NCT04416919
org study id: 11887
nct id: NCT04416919
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the safety and efficiency of an assembled modified
      mask in protecting health care workers against Coronavirus in case of any personal protective
      equipment shortage. At least 20 healthy participants will be recruited to try the modified
      mask. The modified masks will be made from masks that are already available as well as
      filters available in the pulmonary department at the Oklahoma City VA Health Care System
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Success Percentage
time frame: 15 minutes
description: Conduct a quantitative fit test and calculate the percentage of participants who pass the test.
measure: End-tidal CO2 Variation. Description: mmHg.
time frame: at 0 and 15 minutes
description: Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask
measure: Oxygen Pulse Oximetry Variation. Description: mmHg.
time frame: at 0 and 15 minutes.
description: Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask
measure: Mask Visibility. Description: Likert Scale.
time frame: 15 minutes
description: Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes
measure: Willingness of usage. Description: Likert Scale.
time frame: after 15 minutes
description: When the mask is removed, participants will be asked about willingness to use this mask compared to N-95 masks using a 5-point Likert scale from 'Very unlikely' to 'Very likely'.
arm group label: Assembled Mask
arm group type: Other
description: Participant will be fitted with a full-face mask that covers the mouth and nose or a Whole face mask that covers the eyes, nose, and mouth depending on participant's preferences. The Fitted Mask will be attached to a bacterial/viral filter for fit testing. After completing the Fit test, the mask will be placed on the face for 15 minutes while the participant performs various activities to document the ability to tolerate the respirator. Participants oxygen and carbon dioxide level will be measured in the beginning and at the end of the 15 minutes. The individuals will be able to remove the Mask anytime if they experience significant discomfort or claustrophobia. At the end, the mask will be removed.
intervention type: Other
intervention name: Assembled mask
description: Assembled masks consisting of 3 parts: A facemask (Respironics Performax Whole Face Mask or Hans Rudolph mask naso-oral mask) linked by a blue elbow ( RP Performax SE ELBOW) to a ventilator filter (Teleflex Bacterial/Viral filter 1605 or Iso-Gard HEPA light Filter 28022)
arm group label: Assembled Mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Houssein Youness, MD
role: Principal Investigator
affiliation: University of Oklahoma HSC - OKC Veterans Affairs Medical Center
facility: 
country: United States
citation: Prevention CfDCa. Strategies for Optimizing the Supply of Facemasks: COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face-masks.html
citation: van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
PMID: 32182409
citation: Qian Y, Willeke K, Grinshpun SA, Donnelly J, Coffey CC. Performance of N95 respirators: filtration efficiency for airborne microbial and inert particles. Am Ind Hyg Assoc J. 1998 Feb;59(2):128-32. doi: 10.1080/15428119891010389.
PMID: 9487666
responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No