<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/NCT03790683</url>
  </required_header>
  <id_info>
    <org_study_id>TJ Intraoperative warming</org_study_id>
    <nct_id>NCT03790683</nct_id>
  </id_info>
  <brief_title>Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System</brief_title>
  <official_title>Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Cooling Therapy, Inc., d/b/a Attune Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Advanced Cooling Therapy, Inc., d/b/a Attune Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the effectiveness of EnsoETM as a supplemental warming&#xD;
      device compared to the standard of care warming practice in patients having major surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maintaining patient's body temperature is of major importance in patients undergoing surgical&#xD;
      procedures and existing methods to warm patients to maintain perioperative normothermia have&#xD;
      limitations. This results in as many as half of patients undergoing surgery developing&#xD;
      inadvertent hypothermia during and/or after their procedure. The EnsoETM is an Esophageal&#xD;
      Temperature Management (ETM) device consisting of a multi-chambered silicone tube connected&#xD;
      to a heat exchanger and placed in the esophagus, providing highly efficient heat transfer to&#xD;
      a patient. The EnsoETM potentially improves the ability to control patient temperature by&#xD;
      eliminating the disadvantages of existing methods while maintaining the functionality of the&#xD;
      orogastric tube that it replaces.&#xD;
&#xD;
      The primary objective of this study is to measure the number of degree-hours spent below 37°C&#xD;
      intraoperatively and until recovery in the PACU. This measure will be compared between&#xD;
      patients having standard management of body temperature to patients having the EnsoETM placed&#xD;
      as an additional warming device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor funding limitations&#xD;
  </why_stopped>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>
    <intervention_model_description>prospective, randomized interventional study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inadvertent Hypothermia Prevention</measure>
    <time_frame>Time from intubation until extubation, approximately 3-12 hours</time_frame>
    <description>Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time From Intubation Until Extubation</measure>
    <time_frame>perioperative, approximately 3-12 hours</time_frame>
    <description>Time from intubation until extubation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Hypothermia Following Anesthesia</condition>
  <condition>Hypothermia</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>EnsoETM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive esophageal warming. Original study design anticipated esophageal warming in addition to standard of care surface warming from the time they enter the OR until released to the PACU. After 7 patients, protocol was adjusted to specify only esophageal warming unless addition of surface warming was warranted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EnsoETM</intervention_name>
    <description>Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia. Addition of standard of care surface warming was specified as optional after first 7 patients.</description>
    <arm_group_label>EnsoETM</arm_group_label>
    <other_name>ECD02, Esophageal Cooling Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surface Warming</intervention_name>
    <description>Forced air warming device will be placed on the patient according to standard practice.</description>
    <arm_group_label>EnsoETM</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
    <other_name>Bair Hugger, forced air blanket</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of signed and dated informed consent form&#xD;
&#xD;
          -  Male or female, ages 18 years and older&#xD;
&#xD;
          -  Scheduled for major surgical procedures requiring general anesthesia and with no known&#xD;
             contraindication to having an orogastric tube placed for the duration of the surgery&#xD;
&#xD;
          -  The time in the OR is expected to last at least 180 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Esophageal strictures (risk of perforation)&#xD;
&#xD;
          -  Patients with known esophageal deformity or evidence of esophageal trauma (for example&#xD;
             history of esophagectomy, previous swallowing disorders, achalasia, etc.)&#xD;
&#xD;
          -  Known ingestion of acidic or caustic poisons within the prior 24 hours.&#xD;
&#xD;
          -  Patients with &lt;40 kg of body mass&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Severe facial trauma&#xD;
&#xD;
          -  Surgical procedures lasting less than 3 hours&#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>Coleen Vernick, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <results_first_submitted>September 6, 2022</results_first_submitted>
  <results_first_submitted_qc>October 3, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 27, 2022</results_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intraoperative hypothermia</keyword>
  <keyword>inadvertent hypothermia</keyword>
  <keyword>perioperative hypothermia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03790683/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>EnsoETM</title>
          <description>Participants receive esophageal warming only from the time they enter the OR until released to the PACU.&#xD;
EnsoETM: Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.&#xD;
Surface Warming: Forced air warming device will be placed on the patient according to standard practice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>EnsoETM</title>
          <description>Participants receive esophageal warming only from the time they enter the OR until released to the PACU.&#xD;
EnsoETM: Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.&#xD;
Surface Warming: Forced air warming device will be placed on the patient according to standard practice.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.4" spread="14.3"/>
                    <measurement group_id="B2" value="65.4" spread="7.4"/>
                    <measurement group_id="B3" value="61.9" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Inadvertent Hypothermia Prevention</title>
        <description>Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.</description>
        <time_frame>Time from intubation until extubation, approximately 3-12 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EnsoETM</title>
            <description>Participants receive esophageal warming only from the time they enter the OR until released to the PACU.&#xD;
EnsoETM: Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.&#xD;
Surface Warming: Forced air warming device will be placed on the patient according to standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Inadvertent Hypothermia Prevention</title>
          <description>Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.</description>
          <units>degrees Celsius*hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.85" spread=".36"/>
                    <measurement group_id="O2" value="4.25" spread=".41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Intubation Until Extubation</title>
        <description>Time from intubation until extubation</description>
        <time_frame>perioperative, approximately 3-12 hours</time_frame>
        <population>Data were not collected and the outcome cannot be reported.</population>
        <group_list>
          <group group_id="O1">
            <title>EnsoETM</title>
            <description>Participants receive esophageal warming only from the time they enter the OR until released to the PACU.&#xD;
EnsoETM: Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.&#xD;
Surface Warming: Forced air warming device will be placed on the patient according to standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Intubation Until Extubation</title>
          <description>Time from intubation until extubation</description>
          <population>Data were not collected and the outcome cannot be reported.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During and up to 24 hours after surgery, a total of approximately 36 hours.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>EnsoETM</title>
          <description>Participants receive esophageal warming only from the time they enter the OR until released to the PACU.&#xD;
EnsoETM: Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.&#xD;
Surface Warming: Forced air warming device will be placed on the patient according to standard practice.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marc C. Torjman, Ph.D.</name_or_title>
      <organization>Sidney Kimmel Medical College, Thomas Jefferson University and Hospitals</organization>
      <phone>(215) 955-5275</phone>
      <email>Marc.Torjman@Jefferson.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03790683
org study id: TJ Intraoperative warming
nct id: NCT03790683
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The aim of this study is to assess the effectiveness of EnsoETM as a supplemental warming
      device compared to the standard of care warming practice in patients having major surgery.
Maintaining patient's body temperature is of major importance in patients undergoing surgical
      procedures and existing methods to warm patients to maintain perioperative normothermia have
      limitations. This results in as many as half of patients undergoing surgery developing
      inadvertent hypothermia during and/or after their procedure. The EnsoETM is an Esophageal
      Temperature Management (ETM) device consisting of a multi-chambered silicone tube connected
      to a heat exchanger and placed in the esophagus, providing highly efficient heat transfer to
      a patient. The EnsoETM potentially improves the ability to control patient temperature by
      eliminating the disadvantages of existing methods while maintaining the functionality of the
      orogastric tube that it replaces.

      The primary objective of this study is to measure the number of degree-hours spent below 37°C
      intraoperatively and until recovery in the PACU. This measure will be compared between
      patients having standard management of body temperature to patients having the EnsoETM placed
      as an additional warming device.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized interventional study
primary purpose: Prevention
masking: None (Open Label)
measure: Inadvertent Hypothermia Prevention
time frame: Time from intubation until extubation, approximately 3-12 hours
description: Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.
measure: Time From Intubation Until Extubation
time frame: perioperative, approximately 3-12 hours
description: Time from intubation until extubation
arm group label: EnsoETM
arm group type: Experimental
description: Participants receive esophageal warming. Original study design anticipated esophageal warming in addition to standard of care surface warming from the time they enter the OR until released to the PACU. After 7 patients, protocol was adjusted to specify only esophageal warming unless addition of surface warming was warranted.
arm group label: Standard of Care
arm group type: Active Comparator
description: Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.
intervention type: Device
intervention name: EnsoETM
description: Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia. Addition of standard of care surface warming was specified as optional after first 7 patients.
arm group label: EnsoETM
other name: ECD02, Esophageal Cooling Device
intervention type: Device
intervention name: Surface Warming
description: Forced air warming device will be placed on the patient according to standard practice.
arm group label: EnsoETM
arm group label: Standard of Care
other name: Bair Hugger, forced air blanket
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Coleen Vernick, DO
role: Principal Investigator
affiliation: Thomas Jefferson University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypothermia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 