<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/NCT02993666</url>
  </required_header>
  <id_info>
    <org_study_id>JHSeo_FAW</org_study_id>
    <nct_id>NCT02993666</nct_id>
  </id_info>
  <brief_title>Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      This study is conducted to evaluate the effectiveness of forced air warming using upper and&#xD;
      lower body blankets by measuring core body temperature in patients undergoing video-assisted&#xD;
      thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intraoperative incidence of hypothermia</measure>
    <time_frame>through surgery completion, up to 4 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Core Body Temperature</condition>
  <arm_group>
    <arm_group_label>upper body</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>warming with upper body blankets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lower body</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>warming with lower body blankets</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bair Hugger</intervention_name>
    <description>forced air warming with Bair Hugger air warmer</description>
    <arm_group_label>lower body</arm_group_label>
    <arm_group_label>upper body</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing video-assisted thoracic surgery over 2 hours&#xD;
&#xD;
          -  ASA I, II and III&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to enroll&#xD;
&#xD;
          -  patients with fever or hypothermia before surgery&#xD;
&#xD;
          -  patients who required changes of position during surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JH Seo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>June 9, 2017</last_update_submitted>
  <last_update_submitted_qc>June 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong-Hwa Seo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02993666
org study id: JHSeo_FAW
nct id: NCT02993666
lead sponsor: 
This study is conducted to evaluate the effectiveness of forced air warming using upper and
      lower body blankets by measuring core body temperature in patients undergoing video-assisted
      thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: intraoperative incidence of hypothermia
time frame: through surgery completion, up to 4 hours
arm group label: upper body
arm group type: Experimental
description: warming with upper body blankets
arm group label: lower body
arm group type: Experimental
description: warming with lower body blankets
intervention type: Device
intervention name: Bair Hugger
description: forced air warming with Bair Hugger air warmer
arm group label: lower body
arm group label: upper body
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: JH Seo
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong-Hwa Seo
investigator title: Professor