<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/NCT04427267</url>
  </required_header>
  <id_info>
    <org_study_id>PPE-02</org_study_id>
    <nct_id>NCT04427267</nct_id>
  </id_info>
  <brief_title>Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients</brief_title>
  <official_title>Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal State Budgetary Scientific Institution &quot;Izmerov Research Institute of Occupational Health&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal State Budgetary Scientific Institution &quot;Izmerov Research Institute of Occupational Health&quot;</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>
      This research will provide data on thermal condition of medical workers who use personal&#xD;
      protective equipment from biological hazards. Aquired data will be used to define acceptable&#xD;
      period of use for these protective costumes.&#xD;
&#xD;
      This research will recruit 6 volunteers. During 6 hours each subject will perform their work&#xD;
      using protective costume. Heart rate, skin and air temperature under costume and hygrometric&#xD;
      data will be registered. Also there will be questionnaires for volunteers for subjective&#xD;
      assessment of thermal and moisture sensations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Actual">June 27, 2020</completion_date>
  <primary_completion_date type="Actual">June 27, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Skin thermometry</measure>
    <time_frame>6 hours</time_frame>
    <description>DS1923-F5 Thermochron iButtons</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hygrometry under costume</measure>
    <time_frame>6 hours</time_frame>
    <description>DS1923-F5 Thermochron iButtons</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>6 hours</time_frame>
    <description>A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Air thermometry</measure>
    <time_frame>6 hours</time_frame>
    <description>Meteoscop - M</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Air hygrometry</measure>
    <time_frame>6 hours</time_frame>
    <description>Meteoscop - M</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">6</enrollment>
  <condition>Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients</condition>
  <arm_group>
    <arm_group_label>Health workers</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personal protective equipment from biological hazard</intervention_name>
    <description>Includes: isolation clothing, mask, eyewear, overshoes</description>
    <arm_group_label>Health workers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Health workers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy individuals (based on medical screening)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  endocrinological diseases and disorders&#xD;
&#xD;
          -  health deviations at the time of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health</name>
      <address>
        <city>Moscow</city>
        <zip>105275</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 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>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal State Budgetary Scientific Institution &quot;Izmerov Research Institute of Occupational Health&quot;</investigator_affiliation>
    <investigator_full_name>Andrey Mikhailovich Geregey</investigator_full_name>
    <investigator_title>Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey</investigator_title>
  </responsible_party>
  <keyword>Thermophysiology</keyword>
  <keyword>Personal protective equipment from biological hazards</keyword>
  <keyword>Medical workers</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Disease</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/NCT04427267
org study id: PPE-02
nct id: NCT04427267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research will provide data on thermal condition of medical workers who use personal
      protective equipment from biological hazards. Aquired data will be used to define acceptable
      period of use for these protective costumes.

      This research will recruit 6 volunteers. During 6 hours each subject will perform their work
      using protective costume. Heart rate, skin and air temperature under costume and hygrometric
      data will be registered. Also there will be questionnaires for volunteers for subjective
      assessment of thermal and moisture sensations.
observational model: Case-Control
time perspective: Prospective
measure: Skin thermometry
time frame: 6 hours
description: DS1923-F5 Thermochron iButtons
measure: Hygrometry under costume
time frame: 6 hours
description: DS1923-F5 Thermochron iButtons
measure: Heart rate
time frame: 6 hours
description: A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research
measure: Air thermometry
time frame: 6 hours
description: Meteoscop - M
measure: Air hygrometry
time frame: 6 hours
description: Meteoscop - M
arm group label: Health workers
intervention type: Other
intervention name: Personal protective equipment from biological hazard
description: Includes: isolation clothing, mask, eyewear, overshoes
arm group label: Health workers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
investigator full name: Andrey Mikhailovich Geregey
investigator title: Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey
mesh term: COVID-19
mesh term: Disease
sharing ipd: No