xml: <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/NCT05996757</url>
    </required_header>
    <id_info>
      <org_study_id>2017/150</org_study_id>
      <nct_id>NCT05996757</nct_id>
    </id_info>
    <brief_title>Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia</brief_title>
    <official_title>Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Haukeland University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Haukeland University Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 optimal method of prehospital insulation and rewarming of hypothermic patients have been&#xD;
        subject of debate, and there is a substantial lack og high-quality evidence to guide&#xD;
        providers.&#xD;
  &#xD;
        One question concerns whether or not the patients clothing should be removed prior to being&#xD;
        wrapped in an insulating model with a vapor barrier. Evaporative heat loss is one of four&#xD;
        mechanisms of heat loss, and preventing evaporative heat loss should be a prioritized task&#xD;
        for providers. Removal of wet clothing usually means subjecting the patient to the&#xD;
        environment, but will reduce the evaporative heat loss considerably. An other alternative is&#xD;
        to encapsulate the patient in a vapor barrier. Evaporative heat loss will stop when the&#xD;
        humidity inside the vapor barrier reaches 100%.&#xD;
  &#xD;
        We aim to investigate whether it is recommended to removed wet clothing or encase the patient&#xD;
        in a vapor barrier.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 20, 2017</start_date>
    <completion_date type="Actual">March 21, 2017</completion_date>
    <primary_completion_date type="Actual">March 21, 2017</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean skin temperature</measure>
      <time_frame>60 minutes</time_frame>
      <description>Change in mean skin temperature during rewarming phase</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Subjective thermal comfort and shivering</measure>
      <time_frame>60 minutes</time_frame>
      <description>Using a validated questionnaire at regular intervals</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">8</enrollment>
    <condition>Accidental Hypothermia</condition>
    <condition>Emergencies</condition>
    <arm_group>
      <arm_group_label>Wet clothing removal</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Vapor barrier</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Wet clothing removal</intervention_name>
      <description>The participants in the intervention group will have their clothing removed prior to insulation.</description>
      <arm_group_label>Wet clothing removal</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18&#xD;
  &#xD;
            -  American Society of Anaesthesiologists class 1&#xD;
  &#xD;
            -  No nicotine use&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute illness on study day, fever or malaise&#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>Øyvind Thomassen, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Haukeland University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Haukeland University Hospital</name>
        <address>
          <city>Bergen</city>
          <country>Norway</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <results_reference>
      <citation>Henriksson O, Lundgren PJ, Kuklane K, Holmer I, Giesbrecht GG, Naredi P, Bjornstig U. Protection against cold in prehospital care: wet clothing removal or addition of a vapor barrier. Wilderness Environ Med. 2015 Mar;26(1):11-20. doi: 10.1016/j.wem.2014.07.001.</citation>
      <PMID>25712295</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Accidental hypothermia</keyword>
    <keyword>Mountain Medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Hypothermia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996757
  org study id: 2017/150
  nct id: NCT05996757
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The optimal method of prehospital insulation and rewarming of hypothermic patients have been
        subject of debate, and there is a substantial lack og high-quality evidence to guide
        providers.
  
        One question concerns whether or not the patients clothing should be removed prior to being
        wrapped in an insulating model with a vapor barrier. Evaporative heat loss is one of four
        mechanisms of heat loss, and preventing evaporative heat loss should be a prioritized task
        for providers. Removal of wet clothing usually means subjecting the patient to the
        environment, but will reduce the evaporative heat loss considerably. An other alternative is
        to encapsulate the patient in a vapor barrier. Evaporative heat loss will stop when the
        humidity inside the vapor barrier reaches 100%.
  
        We aim to investigate whether it is recommended to removed wet clothing or encase the patient
        in a vapor barrier.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Mean skin temperature
  time frame: 60 minutes
  description: Change in mean skin temperature during rewarming phase
  measure: Subjective thermal comfort and shivering
  time frame: 60 minutes
  description: Using a validated questionnaire at regular intervals
  arm group label: Wet clothing removal
  arm group type: Active Comparator
  arm group label: Vapor barrier
  arm group type: No Intervention
  intervention type: Procedure
  intervention name: Wet clothing removal
  description: The participants in the intervention group will have their clothing removed prior to insulation.
  arm group label: Wet clothing removal
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Øyvind Thomassen, MD, PhD
  role: Principal Investigator
  affiliation: Haukeland University Hospital
  facility: 
  country: Norway
  citation: Henriksson O, Lundgren PJ, Kuklane K, Holmer I, Giesbrecht GG, Naredi P, Bjornstig U. Protection against cold in prehospital care: wet clothing removal or addition of a vapor barrier. Wilderness Environ Med. 2015 Mar;26(1):11-20. doi: 10.1016/j.wem.2014.07.001.
  PMID: 25712295
  responsible party type: Sponsor
  mesh term: Emergencies
  mesh term: Hypothermia
  sharing ipd: No