<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/NCT02186210</url>
  </required_header>
  <id_info>
    <org_study_id>Prewarming_OPCAB</org_study_id>
    <nct_id>NCT02186210</nct_id>
  </id_info>
  <brief_title>Effect of Prewarming on Microcirculatory Response</brief_title>
  <official_title>Effect of Prewarming on Microcirculatory Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial&#xD;
      injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery&#xD;
      without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is&#xD;
      important for clinical outcome. The investigators hypothesized that prewarming during&#xD;
      induction of general anesthesia would reduce drop of body temperature and change of&#xD;
      peripheral microcirculation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Microcirculatory parameters can be obtained from vascular occlusion test. Among those&#xD;
      parameters, recovery slope during vascular occlusion test is known to reflect recruitment of&#xD;
      microvasculature in response to hypoxic or ischemic insult. In this study, we will compare&#xD;
      the recovery slope during vascular occlusion test between prewarming treatment group and&#xD;
      control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery Slope</measure>
    <time_frame>3 hours after induction of anesthesia</time_frame>
    <description>We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tissue Oxygen Saturation</measure>
    <time_frame>During the surgery, an average of 4 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Coronary Artery Bypass Graft Triple Vessel</condition>
  <arm_group>
    <arm_group_label>prewarming</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>prewarming during induction of anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no prewarming during induction of anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>prewarming</intervention_name>
    <description>recovery slope StO2</description>
    <arm_group_label>prewarming</arm_group_label>
    <other_name>prewarming by active air heater</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  off-pump coronary artery bypass surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to enroll&#xD;
&#xD;
          -  cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe&#xD;
             peripheral vascular disease, presence of A-V fistula&#xD;
&#xD;
          -  preoperative left ventricular ejection fraction &lt; 35%&#xD;
&#xD;
          -  preoperative continuous infusion of vasopressor or inotropes&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunseok Jeon, PhD</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>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>March 2, 2017</results_first_submitted>
  <results_first_submitted_qc>January 29, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 29, 2018</results_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microcirculation</keyword>
  <keyword>off-pump coronary artery bypass surgery</keyword>
  <keyword>tissue oxygen saturation</keyword>
  <keyword>vascular occlusion test</keyword>
  <keyword>recovery slope</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prewarming</title>
          <description>prewarming during induction of anesthesia&#xD;
prewarming: recovery slope StO2</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>no prewarming during induction of anesthesia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </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>Prewarming</title>
          <description>prewarming during induction of anesthesia&#xD;
prewarming: recovery slope StO2</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>no prewarming during induction of anesthesia</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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" spread="9"/>
                    <measurement group_id="B2" value="66" spread="8"/>
                    <measurement group_id="B3" value="65" spread="8"/>
                  </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="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </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>Korea, Republic of</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Recovery Slope</title>
        <description>We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.</description>
        <time_frame>3 hours after induction of anesthesia</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prewarming</title>
            <description>prewarming during induction of anesthesia&#xD;
prewarming: recovery slope StO2</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>no prewarming during induction of anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Recovery Slope</title>
          <description>We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.</description>
          <units>% / sec (recovery slope unit)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="1.0"/>
                    <measurement group_id="O2" value="3.1" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tissue Oxygen Saturation</title>
        <time_frame>During the surgery, an average of 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prewarming</title>
            <description>prewarming during induction of anesthesia at 3 hr after induction</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>no prewarming during induction of anesthesia at 3 hr after induction</description>
          </group>
        </group_list>
        <measure>
          <title>Tissue Oxygen Saturation</title>
          <units>% (percent of tissue saturation)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="10"/>
                    <measurement group_id="O2" value="79" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prewarming</title>
          <description>prewarming during induction of anesthesia&#xD;
prewarming: recovery slope StO2</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>no prewarming during induction of anesthesia</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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 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>Dr Yunseok Jeon</name_or_title>
      <organization>Seoul National University Hospital Dept of Anesthesiology</organization>
      <phone>82-2-2072-2465</phone>
      <email>jeonyunseok@gmail.com</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/NCT02186210
org study id: Prewarming_OPCAB
nct id: NCT02186210
lead sponsor: 
has dmc: Yes
Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial
      injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery
      without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is
      important for clinical outcome. The investigators hypothesized that prewarming during
      induction of general anesthesia would reduce drop of body temperature and change of
      peripheral microcirculation.
Microcirculatory parameters can be obtained from vascular occlusion test. Among those
      parameters, recovery slope during vascular occlusion test is known to reflect recruitment of
      microvasculature in response to hypoxic or ischemic insult. In this study, we will compare
      the recovery slope during vascular occlusion test between prewarming treatment group and
      control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Recovery Slope
time frame: 3 hours after induction of anesthesia
description: We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.
measure: Tissue Oxygen Saturation
time frame: During the surgery, an average of 4 hours
arm group label: prewarming
arm group type: Experimental
description: prewarming during induction of anesthesia
arm group label: control
arm group type: No Intervention
description: no prewarming during induction of anesthesia
intervention type: Device
intervention name: prewarming
description: recovery slope StO2
arm group label: prewarming
other name: prewarming by active air heater
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yunseok Jeon, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 