<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/NCT02200055</url>
  </required_header>
  <id_info>
    <org_study_id>CIP# 12-0050</org_study_id>
    <nct_id>NCT02200055</nct_id>
  </id_info>
  <brief_title>Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need</brief_title>
  <official_title>The Use of Multifrequency Bioimpedance Assessments as an Estimate of Perioperative Total Body Volume and Postoperative Fluid Resuscitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United States Naval Medical Center, Portsmouth</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United States Naval Medical Center, Portsmouth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Being able to accurately monitor patient bodily fluid levels during and after surgery is very&#xD;
      important, as there are a number of complications that can arise if a patient's fluid levels&#xD;
      become unbalanced, such as swelling within or pressure on various bodily organ systems. There&#xD;
      are several different ways that physicians can monitor a patient's fluid balance during and&#xD;
      after surgery, such as measuring the amount of urine output or the use of central venous&#xD;
      catheters which measure the pressure in the veins entering the heart. Most of these&#xD;
      techniques are invasive since they require tubes to be inserted into the body. A potential&#xD;
      alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA).&#xD;
&#xD;
      Bioimpedance assessments work by using small electrical currents that can accurately predict&#xD;
      both the water surrounding the outside of cells in the body, as well as the total amount of&#xD;
      water in the entire body. Electrical bioimpedance assessments have been used to estimate&#xD;
      patient swelling following surgery (edema), to measure the volume of blood the heart is&#xD;
      pumping out, as well as to calculate body fat percentages.&#xD;
&#xD;
      The goal of this study is to relate this technology to fluid shifts within the body that&#xD;
      occur as a result of surgery, in particular, major intra-abdominal surgeries. By using&#xD;
      bioimpedance during and after surgery, the investigators will compare the data collected with&#xD;
      that calculated by using traditional measures of body fluid status, such as urine output and&#xD;
      intraoperative blood loss. During the study, the bioimpedance monitors will not replace the&#xD;
      standard bodily fluid monitors and will not interfere with their readings. Additionally, the&#xD;
      electrical current produced by the bioimpedance monitors is too small for patients to feel&#xD;
      and will not interfere with medical devices such as pacemakers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Being able to accurately monitor patient bodily fluid levels during and after surgery is very&#xD;
      important, as there are a number of complications that can arise if a patient's fluid levels&#xD;
      become unbalanced, such as swelling within or pressure on various bodily organ systems. There&#xD;
      are several different ways that physicians can monitor a patient's fluid balance during and&#xD;
      after surgery, such as measuring the amount of urine output or the use of central venous&#xD;
      catheters which measure the pressure in the veins entering the heart. Most of these&#xD;
      techniques are invasive since they require tubes to be inserted into the body. A potential&#xD;
      alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA).&#xD;
&#xD;
      Bioimpedance assessments work by using small electrical currents that can accurately predict&#xD;
      both the water surrounding the outside of cells in the body, as well as the total amount of&#xD;
      water in the entire body. Electrical bioimpedance assessments have been used to estimate&#xD;
      patient swelling following surgery (edema), to measure the volume of blood the heart is&#xD;
      pumping out, as well as to calculate body fat percentages.&#xD;
&#xD;
      The goal of this study is to relate this technology to fluid shifts within the body that&#xD;
      occur as a result of surgery, in particular, major intra-abdominal surgeries. By using&#xD;
      bioimpedance during and after surgery, the investigators will compare the data collected with&#xD;
      that calculated by using traditional measures of body fluid status, such as urine output and&#xD;
      intraoperative blood loss. During the study, the bioimpedance monitors will not replace the&#xD;
      standard bodily fluid monitors and will not interfere with their readings. Additionally, the&#xD;
      electrical current produced by the bioimpedance monitors is too small for patients to feel&#xD;
      and will not interfere with medical devices such as pacemakers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bioimpedance Assessment</measure>
    <time_frame>preoperative measurement</time_frame>
    <description>Bioimpedance assessment measurements were recorded for each participant before the surgical procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bioimpedance Assessment</measure>
    <time_frame>6 hours postoperative measurement</time_frame>
    <description>Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bioimpedance Assessment</measure>
    <time_frame>Average measurement, in ohms, taken daily for approximately 8-10 days</time_frame>
    <description>Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Extracellular Water Volume</measure>
    <time_frame>preoperative measurement</time_frame>
    <description>Extracellular water volume was recorded for each participant before surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Intracellular Water Volume</measure>
    <time_frame>6 hour postoperative measurement</time_frame>
    <description>Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Extracellular Water Volume</measure>
    <time_frame>6 hours postoperative measurement</time_frame>
    <description>Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Intracellular Water Volume</measure>
    <time_frame>Preoperative measurement</time_frame>
    <description>Intracellular water volume was recorded for each participant before surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Fluid Balance (Intakes and Outputs)</measure>
    <time_frame>Sum of intakes and outputs each day while inpatient, an average of 8 days</time_frame>
    <description>Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine Output</measure>
    <time_frame>preoperative measurement</time_frame>
    <description>Overall urine output was collected preoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study Characteristics of Participants: Body Mass Index</measure>
    <time_frame>baseline measurement</time_frame>
    <description>Body Mass Index was recorded for each study participant at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Society of Anaesthesiologists Physical Status Classification Scale</measure>
    <time_frame>preoperative</time_frame>
    <description>A classification scale to assess the fitness of patients before surgery&#xD;
The ASA score is a subjective assessment of a patient's overall physical health. The scale ranges from 1 to 5.&#xD;
ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Intraoperative Fluids</measure>
    <time_frame>intraoperative measurement</time_frame>
    <description>The amount of IV fluids each patient received during the surgical procedure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Intestinal Cancer</condition>
  <condition>Diverticulitis</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Bioimpedance Assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The only group will be those patients having major intra-abdominal surgical procedures.&#xD;
Each patient involved in the study will be evaluated with a bioimpedance monitor ('Bodystat Quadscan 4000') to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bodystat Quadscan 4000</intervention_name>
    <description>Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
    <arm_group_label>Bioimpedance Assessment</arm_group_label>
    <other_name>Bioimpedance Assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having major intra-abdominal procedures under general anesthesia requiring&#xD;
             hospitalization postoperatively during the initial recovery from surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not having intra-abdominal procedures (ie. Thyroidectomy, open or&#xD;
             laparoscopic inguinal hernia repair, excision of skin lesions, breast procedures)&#xD;
&#xD;
          -  Patients having outpatient surgery&#xD;
&#xD;
          -  Patients having laparoscopic cholecystectomies, laparoscopic or open appendectomies&#xD;
&#xD;
          -  Patients having bariatric surgery (because the bioimpedance assessment technology has&#xD;
             proven to be unreliable in obese populations)&#xD;
&#xD;
          -  Morbidly obese patients (BMI &gt;40)&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Oxner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>United States Naval Medical Center, Portsmouth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center Portsmouth</name>
      <address>
        <city>Portsmouth</city>
        <state>Virginia</state>
        <zip>23708</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 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>March 8, 2018</results_first_submitted>
  <results_first_submitted_qc>August 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 28, 2018</results_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United States Naval Medical Center, Portsmouth</investigator_affiliation>
    <investigator_full_name>Christian McEvoy</investigator_full_name>
    <investigator_title>General Surgery Resident</investigator_title>
  </responsible_party>
  <keyword>Electrical Bioimpedance</keyword>
  <keyword>Major Intra-abdominal Surgical Procedures</keyword>
  <keyword>Total Body Volume</keyword>
  <keyword>Fluid Resuscitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Neoplasms</mesh_term>
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Diverticulitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bioimpedance Assessment</title>
          <description>The only group will be those patients having major intra-abdominal surgical procedures.&#xD;
Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment&#xD;
Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The number of participants meeting study eligibility requirements</population>
      <group_list>
        <group group_id="B1">
          <title>Bioimpedance Assessment</title>
          <description>The only group will be those patients having major intra-abdominal surgical procedures.&#xD;
Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment&#xD;
Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.5" spread="13.9"/>
                  </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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bioimpedance Assessment</title>
        <description>Bioimpedance assessment measurements were recorded for each participant before the surgical procedure</description>
        <time_frame>preoperative measurement</time_frame>
        <population>This is the population of participants with bioimpedance measurements taken preoperative</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>There are no groups for this study</description>
          </group>
        </group_list>
        <measure>
          <title>Bioimpedance Assessment</title>
          <description>Bioimpedance assessment measurements were recorded for each participant before the surgical procedure</description>
          <population>This is the population of participants with bioimpedance measurements taken preoperative</population>
          <units>ohms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bioimpedance Assessment</title>
        <description>Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure</description>
        <time_frame>6 hours postoperative measurement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>There are no groups in this study</description>
          </group>
        </group_list>
        <measure>
          <title>Bioimpedance Assessment</title>
          <description>Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure</description>
          <units>ohms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bioimpedance Assessment</title>
        <description>Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.</description>
        <time_frame>Average measurement, in ohms, taken daily for approximately 8-10 days</time_frame>
        <population>This population of participants has their bioimpedance assessment taken daily for approximately 8-10 days postoperative. One average across this time frame was recorded</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>There are no groups in this study</description>
          </group>
        </group_list>
        <measure>
          <title>Bioimpedance Assessment</title>
          <description>Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.</description>
          <population>This population of participants has their bioimpedance assessment taken daily for approximately 8-10 days postoperative. One average across this time frame was recorded</population>
          <units>ohms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Extracellular Water Volume</title>
        <description>Extracellular water volume was recorded for each participant before surgical procedure.</description>
        <time_frame>preoperative measurement</time_frame>
        <population>This is the final number of participants who met all study eligibility requirements</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>The only group will be those patients having major intra-abdominal surgical procedures.&#xD;
Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment&#xD;
Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Extracellular Water Volume</title>
          <description>Extracellular water volume was recorded for each participant before surgical procedure.</description>
          <population>This is the final number of participants who met all study eligibility requirements</population>
          <units>percent of total water volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="3.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Intracellular Water Volume</title>
        <description>Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.</description>
        <time_frame>6 hour postoperative measurement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>The only group will be those patients having major intra-abdominal surgical procedures.&#xD;
Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment&#xD;
Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Intracellular Water Volume</title>
          <description>Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.</description>
          <units>percent of total water volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Extracellular Water Volume</title>
        <description>Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.</description>
        <time_frame>6 hours postoperative measurement</time_frame>
        <population>This population contains data with extracellular water volume measurements taken post-operative</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>There are no groups in this study</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Extracellular Water Volume</title>
          <description>Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.</description>
          <population>This population contains data with extracellular water volume measurements taken post-operative</population>
          <units>percent of total water volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Intracellular Water Volume</title>
        <description>Intracellular water volume was recorded for each participant before surgical procedure.</description>
        <time_frame>Preoperative measurement</time_frame>
        <population>This population includes data on participants with recorded intracellular water volume measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>The only group will be those patients having major intra-abdominal surgical procedures.&#xD;
Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment&#xD;
Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Intracellular Water Volume</title>
          <description>Intracellular water volume was recorded for each participant before surgical procedure.</description>
          <population>This population includes data on participants with recorded intracellular water volume measurements</population>
          <units>percent of total water volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <non_inferiority_desc>This measurement was collected for each participant. A pre-operative and post-operative bioimpedance measurement was taken.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <method>Chi-squared</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.53</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daily Fluid Balance (Intakes and Outputs)</title>
        <description>Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period</description>
        <time_frame>Sum of intakes and outputs each day while inpatient, an average of 8 days</time_frame>
        <population>This was the final amount of participants who met all study eligibility requirements</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>The only group will be those patients having major intra-abdominal surgical procedures.&#xD;
Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment&#xD;
Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Fluid Balance (Intakes and Outputs)</title>
          <description>Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period</description>
          <population>This was the final amount of participants who met all study eligibility requirements</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1163.1" spread="1061.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urine Output</title>
        <description>Overall urine output was collected preoperative</description>
        <time_frame>preoperative measurement</time_frame>
        <population>This population of participants recorded their urine output under preoperative conditions</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>There are no groups in this study</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Output</title>
          <description>Overall urine output was collected preoperative</description>
          <population>This population of participants recorded their urine output under preoperative conditions</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="406.7" spread="430.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Study Characteristics of Participants: Body Mass Index</title>
        <description>Body Mass Index was recorded for each study participant at baseline</description>
        <time_frame>baseline measurement</time_frame>
        <population>Baseline BMI was recorded for each participant</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>There are no groups in this study</description>
          </group>
        </group_list>
        <measure>
          <title>Study Characteristics of Participants: Body Mass Index</title>
          <description>Body Mass Index was recorded for each study participant at baseline</description>
          <population>Baseline BMI was recorded for each participant</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>American Society of Anaesthesiologists Physical Status Classification Scale</title>
        <description>A classification scale to assess the fitness of patients before surgery&#xD;
The ASA score is a subjective assessment of a patient's overall physical health. The scale ranges from 1 to 5.&#xD;
ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive</description>
        <time_frame>preoperative</time_frame>
        <population>An ASA classification was recorded for each participant</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>There are no groups in this study</description>
          </group>
        </group_list>
        <measure>
          <title>American Society of Anaesthesiologists Physical Status Classification Scale</title>
          <description>A classification scale to assess the fitness of patients before surgery&#xD;
The ASA score is a subjective assessment of a patient's overall physical health. The scale ranges from 1 to 5.&#xD;
ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive</description>
          <population>An ASA classification was recorded for each participant</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Intraoperative Fluids</title>
        <description>The amount of IV fluids each patient received during the surgical procedure</description>
        <time_frame>intraoperative measurement</time_frame>
        <population>The population of participants with recorded data on the amount of IV fluids used during surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Bioimpedance Assessment</title>
            <description>There are no groups in this study</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Intraoperative Fluids</title>
          <description>The amount of IV fluids each patient received during the surgical procedure</description>
          <population>The population of participants with recorded data on the amount of IV fluids used during surgery</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2472.6" spread="1147.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data collected April 2012 - 13November2014. Adverse event data were collected during that time and occurred between 19Aug2013 and 04Oct2014.</time_frame>
      <desc>At NMCP events are categorized as Adverse Events (AEs) or Serious Adverse Events (SAEs), depending on three criteria: Seriousness, expectedness, and relatedness to the research. An SAE must include all three criteria. SAEs are not limited to physical harms. They may include psychological, societal, and financial harms as well, such as psychological pain and embarrassment, loss of social standing, economic injury, loss of employment, potential for legal action, or loss of insurability, etc.</desc>
      <group_list>
        <group group_id="E1">
          <title>Bioimpedance Assessment</title>
          <description>The only group will be those patients having major intra-abdominal surgical procedures.&#xD;
Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment&#xD;
Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.&#xD;
Bioimpedance Assessment</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Other</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="90"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>upper gastrointestinal bleed</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>resulted in re-admission</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>perineal wound infection</sub_title>
                <description>Post-op infection leading to hospital admission</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <description>bronchospasm during surgery</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Other</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>hemoperitoneum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>pancreatic leak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </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>
    <limitations_and_caveats>Due to the number of participants who did not meet study eligibility requirements, we were only able to use 45 of 86 participants' data. Therefore, due such a small sample size, results from this study may lack generalizability.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Christopher Oxner</name_or_title>
      <organization>General Surgery, Naval Medical Center Porstmouth</organization>
      <phone>757-953-2495</phone>
      <email>christopher.r.oxner.mil@mail.mil</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/NCT02200055
org study id: CIP# 12-0050
nct id: NCT02200055
lead sponsor: 
has dmc: No
is fda regulated device: Yes
is us export: No
Being able to accurately monitor patient bodily fluid levels during and after surgery is very
      important, as there are a number of complications that can arise if a patient's fluid levels
      become unbalanced, such as swelling within or pressure on various bodily organ systems. There
      are several different ways that physicians can monitor a patient's fluid balance during and
      after surgery, such as measuring the amount of urine output or the use of central venous
      catheters which measure the pressure in the veins entering the heart. Most of these
      techniques are invasive since they require tubes to be inserted into the body. A potential
      alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA).

      Bioimpedance assessments work by using small electrical currents that can accurately predict
      both the water surrounding the outside of cells in the body, as well as the total amount of
      water in the entire body. Electrical bioimpedance assessments have been used to estimate
      patient swelling following surgery (edema), to measure the volume of blood the heart is
      pumping out, as well as to calculate body fat percentages.

      The goal of this study is to relate this technology to fluid shifts within the body that
      occur as a result of surgery, in particular, major intra-abdominal surgeries. By using
      bioimpedance during and after surgery, the investigators will compare the data collected with
      that calculated by using traditional measures of body fluid status, such as urine output and
      intraoperative blood loss. During the study, the bioimpedance monitors will not replace the
      standard bodily fluid monitors and will not interfere with their readings. Additionally, the
      electrical current produced by the bioimpedance monitors is too small for patients to feel
      and will not interfere with medical devices such as pacemakers.
Being able to accurately monitor patient bodily fluid levels during and after surgery is very
      important, as there are a number of complications that can arise if a patient's fluid levels
      become unbalanced, such as swelling within or pressure on various bodily organ systems. There
      are several different ways that physicians can monitor a patient's fluid balance during and
      after surgery, such as measuring the amount of urine output or the use of central venous
      catheters which measure the pressure in the veins entering the heart. Most of these
      techniques are invasive since they require tubes to be inserted into the body. A potential
      alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA).

      Bioimpedance assessments work by using small electrical currents that can accurately predict
      both the water surrounding the outside of cells in the body, as well as the total amount of
      water in the entire body. Electrical bioimpedance assessments have been used to estimate
      patient swelling following surgery (edema), to measure the volume of blood the heart is
      pumping out, as well as to calculate body fat percentages.

      The goal of this study is to relate this technology to fluid shifts within the body that
      occur as a result of surgery, in particular, major intra-abdominal surgeries. By using
      bioimpedance during and after surgery, the investigators will compare the data collected with
      that calculated by using traditional measures of body fluid status, such as urine output and
      intraoperative blood loss. During the study, the bioimpedance monitors will not replace the
      standard bodily fluid monitors and will not interfere with their readings. Additionally, the
      electrical current produced by the bioimpedance monitors is too small for patients to feel
      and will not interfere with medical devices such as pacemakers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Bioimpedance Assessment
time frame: preoperative measurement
description: Bioimpedance assessment measurements were recorded for each participant before the surgical procedure
measure: Bioimpedance Assessment
time frame: 6 hours postoperative measurement
description: Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure
measure: Bioimpedance Assessment
time frame: Average measurement, in ohms, taken daily for approximately 8-10 days
description: Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.
measure: Percent Extracellular Water Volume
time frame: preoperative measurement
description: Extracellular water volume was recorded for each participant before surgical procedure.
measure: Percent Intracellular Water Volume
time frame: 6 hour postoperative measurement
description: Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.
measure: Percent Extracellular Water Volume
time frame: 6 hours postoperative measurement
description: Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.
measure: Percent Intracellular Water Volume
time frame: Preoperative measurement
description: Intracellular water volume was recorded for each participant before surgical procedure.
measure: Daily Fluid Balance (Intakes and Outputs)
time frame: Sum of intakes and outputs each day while inpatient, an average of 8 days
description: Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period
measure: Urine Output
time frame: preoperative measurement
description: Overall urine output was collected preoperative
measure: Study Characteristics of Participants: Body Mass Index
time frame: baseline measurement
description: Body Mass Index was recorded for each study participant at baseline
measure: American Society of Anaesthesiologists Physical Status Classification Scale
time frame: preoperative
description: A classification scale to assess the fitness of patients before surgery
The ASA score is a subjective assessment of a patient's overall physical health. The scale ranges from 1 to 5.
ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive
measure: Amount of Intraoperative Fluids
time frame: intraoperative measurement
description: The amount of IV fluids each patient received during the surgical procedure
arm group label: Bioimpedance Assessment
arm group type: Experimental
description: The only group will be those patients having major intra-abdominal surgical procedures.
Each patient involved in the study will be evaluated with a bioimpedance monitor ('Bodystat Quadscan 4000') to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.
Bioimpedance Assessment
intervention type: Device
intervention name: Bodystat Quadscan 4000
description: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.
Bioimpedance Assessment
arm group label: Bioimpedance Assessment
other name: Bioimpedance Assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Christopher Oxner, MD
role: Principal Investigator
affiliation: United States Naval Medical Center, Portsmouth
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: United States Naval Medical Center, Portsmouth
investigator full name: Christian McEvoy
investigator title: General Surgery Resident
mesh term: Intestinal Neoplasms
mesh term: Gastroesophageal Reflux
mesh term: Diverticulitis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to the number of participants who did not meet study eligibility requirements, we were only able to use 45 of 86 participants' data. Therefore, due such a small sample size, results from this study may lack generalizability.
point of contact: 