<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/NCT03824262</url>
  </required_header>
  <id_info>
    <org_study_id>E.308215</org_study_id>
    <nct_id>NCT03824262</nct_id>
  </id_info>
  <brief_title>The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position</brief_title>
  <official_title>The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</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 patients scheduled to undergo major abdominal surgery in litotomy position will be&#xD;
      randomized into two groups in order to compare the effects of two warming techniques during&#xD;
      the intraoperative period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be randomized into two groups. All patients will receive prewarming with&#xD;
      forced-air warming device for 30 minutes. All patients will receive warmed fluids during&#xD;
      intraoperative period. One group will receive warming with only forced-air warming device and&#xD;
      the other group will receive warming with both forced-air warming device and water mattress.&#xD;
      Timpanic, esophageal and peripheral temperature monitoring will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">May 4, 2019</completion_date>
  <primary_completion_date type="Actual">May 4, 2019</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body temperature-esophageal probe</measure>
    <time_frame>Perioperative period-every 15 minutes</time_frame>
    <description>Esophageal probe used to measure core body temperature</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body temperature-tympanic thermometer</measure>
    <time_frame>Perioperative period-every 15 minutes</time_frame>
    <description>Tympanic thermometer used to measure body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body temperature-skin thermometer</measure>
    <time_frame>Perioperative period-every 15 minutes</time_frame>
    <description>Skin thermometer used to measure body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of operation</measure>
    <time_frame>Perioperative period</time_frame>
    <description>Duration of operation compared with the change in body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>Perioperative period</time_frame>
    <description>Blood loss during the perioperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shivering after the operation</measure>
    <time_frame>Postoperative 1st hour every 10 minutes</time_frame>
    <description>Assessment of shivering after operation in the recovery room with PAS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to extubation</measure>
    <time_frame>The end of the operation</time_frame>
    <description>Time to extubation at the end of operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Temperature Change, Body</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mistral-Air Plus forced-air warming device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HICO-VARIOTHERM 550</intervention_name>
    <description>Warming during perioperative period.</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mistral-Air Plus forced air warming device</intervention_name>
    <description>Warming during perioperative period.</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major abdominal surgery in litotomy position&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  Anticipated operation time over 1 hour&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  Hypothermia&#xD;
&#xD;
          -  Hyperthermia&#xD;
&#xD;
          -  Malignant Hyperthermia&#xD;
&#xD;
          -  Tyroid dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meral Kanbak, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University, School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>FİLİZ UZUMCUGIL</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University, School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University School of Medicine Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>May 4, 2019</last_update_submitted>
  <last_update_submitted_qc>May 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Filiz Uzumcugil</investigator_full_name>
    <investigator_title>Principal Investigator, MD, Asist. Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Temperature Changes</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/NCT03824262
org study id: E.308215
nct id: NCT03824262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The patients scheduled to undergo major abdominal surgery in litotomy position will be
      randomized into two groups in order to compare the effects of two warming techniques during
      the intraoperative period.
The patients will be randomized into two groups. All patients will receive prewarming with
      forced-air warming device for 30 minutes. All patients will receive warmed fluids during
      intraoperative period. One group will receive warming with only forced-air warming device and
      the other group will receive warming with both forced-air warming device and water mattress.
      Timpanic, esophageal and peripheral temperature monitoring will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Body temperature-esophageal probe
time frame: Perioperative period-every 15 minutes
description: Esophageal probe used to measure core body temperature
measure: Body temperature-tympanic thermometer
time frame: Perioperative period-every 15 minutes
description: Tympanic thermometer used to measure body temperature
measure: Body temperature-skin thermometer
time frame: Perioperative period-every 15 minutes
description: Skin thermometer used to measure body temperature
measure: Duration of operation
time frame: Perioperative period
description: Duration of operation compared with the change in body temperature
measure: Blood loss
time frame: Perioperative period
description: Blood loss during the perioperative period
measure: Shivering after the operation
time frame: Postoperative 1st hour every 10 minutes
description: Assessment of shivering after operation in the recovery room with PAS score
measure: Time to extubation
time frame: The end of the operation
description: Time to extubation at the end of operation
arm group label: Group I
arm group type: Experimental
description: HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device
arm group label: Group II
arm group type: Active Comparator
description: Mistral-Air Plus forced-air warming device
intervention type: Device
intervention name: HICO-VARIOTHERM 550
description: Warming during perioperative period.
arm group label: Group I
intervention type: Device
intervention name: Mistral-Air Plus forced air warming device
description: Warming during perioperative period.
arm group label: Group I
arm group label: Group II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Meral Kanbak, Prof
role: Study Chair
affiliation: Hacettepe University, School of Medicine
last name: FİLİZ UZUMCUGIL
role: Principal Investigator
affiliation: Hacettepe University, School of Medicine
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Filiz Uzumcugil
investigator title: Principal Investigator, MD, Asist. Prof.
mesh term: Body Temperature Changes
sharing ipd: No