<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/NCT02186938</url>
  </required_header>
  <id_info>
    <org_study_id>ENT FloTrac</org_study_id>
    <nct_id>NCT02186938</nct_id>
  </id_info>
  <brief_title>A Prospective Study Evaluating the Use of Intraoperative Stroke Volume Variation Via the FloTrac Device to Guide Fluid and Vasopressor Management in Head and Neck Free Flaps</brief_title>
  <official_title>Does the Intraoperative Use of the FloTrac Device to Guide Fluid and Vasopressor Management Affect Postoperative Morbidity in Patients Receiving a Head and Neck Microvascular Free Tissue Transfer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate whether the intraoperative use of the FloTrac device to guide&#xD;
      fluid and vasopressor management during head and neck free flap surgery improves&#xD;
      postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary&#xD;
      postoperative outcomes include days in ICU, days on ventilator, presence of postoperative&#xD;
      pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap&#xD;
      complication rate, inpatient postoperative cardiorespiratory complications/events, and&#xD;
      overall 30 day flap failure rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Few animal models have shown that intravenous vasopressor administration (including use of&#xD;
      pure alpha agonists such as phenylephrine) can decrease blood flow to free musculocutaneous&#xD;
      flaps (1-3). This has led to a dogmatic belief that all vasopressors should be avoided&#xD;
      intraoperatively during a microvascular free flap reconstruction regardless of patient&#xD;
      hemodynamics, even though there is little published evidence that pressors negatively affect&#xD;
      free flap outcome (4). As a result, these patients often receive generous amounts of fluids&#xD;
      during their intraoperative course to combat periods of hypotension. However, patients&#xD;
      receiving head and neck free tissue transfers tend to be older with serious comorbidities&#xD;
      related to long term tobacco use such as significant cardiovascular and pulmonary disease.&#xD;
      Thus, they often exhibit intraoperative hemodynamic lability with periods of hypotension that&#xD;
      may not necessarily be related to hypovolemia. Consistently treating periods of hypotension&#xD;
      with more intravenous fluids can lead to serious postoperative complications such as graft&#xD;
      failure (4), pulmonary edema, and congestive heart failure. In fact, we have just completed a&#xD;
      retrospective review of 248 patients over a 34 month period that received a head and neck&#xD;
      free tissue transfer; we discovered that a 1ml/kg/hr increase in intraoperative fluid&#xD;
      administration significantly increased 30 day flap complication rate while intraoperative&#xD;
      administration of vasopressors did not affect 30 day flap complication or 30 day failure&#xD;
      rate.&#xD;
&#xD;
      The FloTrac device is an approved and validated medical device that analyzes the arterial&#xD;
      pressure waveform to calculate a stroke volume variation. This stroke volume variation can be&#xD;
      used to better guide intraoperative patient therapy with regard to need for fluid vs. pressor&#xD;
      management during periods of intraoperative hypotension (5). The use of the FloTrac device&#xD;
      for goal directed therapy has been investigated in major abdominal surgery and found to&#xD;
      decrease length of hospital stay and complication rate in this surgical population (5-6).&#xD;
      Thus, it is possible that the intraoperative use of the FloTrac device can better guide&#xD;
      anesthesia providers to provide the necessary therapy for intraoperative hypotension in&#xD;
      patients undergoing head and neck freet tissue transfer, thus improving postoperative&#xD;
      outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ICU Stay</measure>
    <time_frame>Participants were assessed from entry into ICU until departure.</time_frame>
    <description>The primary outcome is length of ICU stay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring a Ventilator</measure>
    <time_frame>The number of participants requiring a ventilator after surgery.</time_frame>
    <description>The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Patients Requiring a Free Flap Surgery</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Arterial line (radial, femoral, dorsalis pedis, or brachial), central line for access when needed, intubation vs tracheostomy, general anesthesia. We currently use stroke-volume variability monitoring (FloTrac) in all patients using the arterial line placed for blood pressure monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study will use a treatment algorithm for patients in the treatment group. This algorithm will aim to maintain a near-normal blood pressure and use goal directed therapy to achieve this. Currently the standard of care is to use IV fluid exclusively in these patients and anesthesia providers everywhere have been challenging that treatment plan. Our algorithm has an iterative approach assessing volume status, cardiac output and vascular tone in order, with interventions specified for each. Individual treatments have been proven safe and effective in this population, we believe this sequence may be the best current management system. By avoiding excessive fluid administration we expect to decrease ICU length of stay due to the comorbidities caused (pulmonary edema, bowl edema, glycocalyx damage).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FloTrac</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults requiring &quot;free flap&quot; tissue reassignment surgery for head and neck cancer at&#xD;
             either MUSC or Vanderbilt Medical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt; 55kg or &gt; 140 kg based on literature regarding accuracy of flotrac.&#xD;
&#xD;
          -  Patients with sustained intraoperative dysrrhythmias based on literature regarding&#xD;
             accuracy of flotrac (ie, atrial flutter, atrial fibrillation).&#xD;
&#xD;
          -  Patients with diagnosed NYHA class III-IV failure or documented EF &lt; 30%&#xD;
&#xD;
          -  Patients with pulmonary disease preventing administration of goal tidal volumes&#xD;
             without excessive inspiratory pressures.&#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>Scott T Reeves, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>June 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>March 16, 2016</results_first_submitted>
  <results_first_submitted_qc>July 24, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2018</results_first_posted>
  <last_update_submitted>August 21, 2018</last_update_submitted>
  <last_update_submitted_qc>August 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>head and neck cancer</keyword>
  <keyword>patients requiring a free flap surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Group</title>
          <description>FloTrac device was used to manage blood pressure during surgery.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47">2012</participants>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Group</title>
          <description>FloTrac device was used to manage blood pressure during surgery.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.</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="47"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="94"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.1" lower_limit="22" upper_limit="81"/>
                    <measurement group_id="B2" value="57.6" lower_limit="18" upper_limit="84"/>
                    <measurement group_id="B3" value="57.7" lower_limit="18" upper_limit="84"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ICU Stay</title>
        <description>The primary outcome is length of ICU stay.</description>
        <time_frame>Participants were assessed from entry into ICU until departure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>FloTrac device was used to manage blood pressure during surgery.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.</description>
          </group>
        </group_list>
        <measure>
          <title>ICU Stay</title>
          <description>The primary outcome is length of ICU stay.</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.7" lower_limit="12.5" upper_limit="102"/>
                    <measurement group_id="O2" value="58.3" lower_limit="2" upper_limit="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring a Ventilator</title>
        <description>The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator</description>
        <time_frame>The number of participants requiring a ventilator after surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>FloTrac device was used to manage blood pressure during surgery.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring a Ventilator</title>
          <description>The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were followed for one year following their surgery.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group</title>
          <description>FloTrac device was used to manage blood pressure during surgery.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.</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="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </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="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr Hand</name_or_title>
      <organization>MUSC</organization>
      <phone>843-792-5442</phone>
      <email>handw@musc.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/NCT02186938
org study id: ENT FloTrac
nct id: NCT02186938
lead sponsor: 
has dmc: Yes
This study aims to investigate whether the intraoperative use of the FloTrac device to guide
      fluid and vasopressor management during head and neck free flap surgery improves
      postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary
      postoperative outcomes include days in ICU, days on ventilator, presence of postoperative
      pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap
      complication rate, inpatient postoperative cardiorespiratory complications/events, and
      overall 30 day flap failure rate.
Few animal models have shown that intravenous vasopressor administration (including use of
      pure alpha agonists such as phenylephrine) can decrease blood flow to free musculocutaneous
      flaps (1-3). This has led to a dogmatic belief that all vasopressors should be avoided
      intraoperatively during a microvascular free flap reconstruction regardless of patient
      hemodynamics, even though there is little published evidence that pressors negatively affect
      free flap outcome (4). As a result, these patients often receive generous amounts of fluids
      during their intraoperative course to combat periods of hypotension. However, patients
      receiving head and neck free tissue transfers tend to be older with serious comorbidities
      related to long term tobacco use such as significant cardiovascular and pulmonary disease.
      Thus, they often exhibit intraoperative hemodynamic lability with periods of hypotension that
      may not necessarily be related to hypovolemia. Consistently treating periods of hypotension
      with more intravenous fluids can lead to serious postoperative complications such as graft
      failure (4), pulmonary edema, and congestive heart failure. In fact, we have just completed a
      retrospective review of 248 patients over a 34 month period that received a head and neck
      free tissue transfer; we discovered that a 1ml/kg/hr increase in intraoperative fluid
      administration significantly increased 30 day flap complication rate while intraoperative
      administration of vasopressors did not affect 30 day flap complication or 30 day failure
      rate.

      The FloTrac device is an approved and validated medical device that analyzes the arterial
      pressure waveform to calculate a stroke volume variation. This stroke volume variation can be
      used to better guide intraoperative patient therapy with regard to need for fluid vs. pressor
      management during periods of intraoperative hypotension (5). The use of the FloTrac device
      for goal directed therapy has been investigated in major abdominal surgery and found to
      decrease length of hospital stay and complication rate in this surgical population (5-6).
      Thus, it is possible that the intraoperative use of the FloTrac device can better guide
      anesthesia providers to provide the necessary therapy for intraoperative hypotension in
      patients undergoing head and neck freet tissue transfer, thus improving postoperative
      outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: ICU Stay
time frame: Participants were assessed from entry into ICU until departure.
description: The primary outcome is length of ICU stay.
measure: Number of Participants Requiring a Ventilator
time frame: The number of participants requiring a ventilator after surgery.
description: The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator
arm group label: Usual Care
arm group type: No Intervention
description: Arterial line (radial, femoral, dorsalis pedis, or brachial), central line for access when needed, intubation vs tracheostomy, general anesthesia. We currently use stroke-volume variability monitoring (FloTrac) in all patients using the arterial line placed for blood pressure monitoring.
arm group label: Treatment
arm group type: Experimental
description: The study will use a treatment algorithm for patients in the treatment group. This algorithm will aim to maintain a near-normal blood pressure and use goal directed therapy to achieve this. Currently the standard of care is to use IV fluid exclusively in these patients and anesthesia providers everywhere have been challenging that treatment plan. Our algorithm has an iterative approach assessing volume status, cardiac output and vascular tone in order, with interventions specified for each. Individual treatments have been proven safe and effective in this population, we believe this sequence may be the best current management system. By avoiding excessive fluid administration we expect to decrease ICU length of stay due to the comorbidities caused (pulmonary edema, bowl edema, glycocalyx damage).
intervention type: Device
intervention name: FloTrac
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott T Reeves, MD
role: Study Chair
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 