<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/NCT02986789</url>
  </required_header>
  <id_info>
    <org_study_id>BIGT0001</org_study_id>
    <nct_id>NCT02986789</nct_id>
  </id_info>
  <brief_title>Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes</brief_title>
  <official_title>Evaluation of Impacts of Continuous Non-Invasive Intra-Operative Hemoglobin and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masimo Corporation</source>
  <oversight_info>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring&#xD;
      using pulse-oximetry based technologies and their effect on the management of transfusion and&#xD;
      infusion decisions and clinical outcomes for the surgical patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">December 15, 2016</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Volume of Allogenic RBC Transfused Intra-operatively</measure>
    <time_frame>Approximately 6-8 hours</time_frame>
    <description>Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinicians will be performing blood transfusions using hospital standard of care procedures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evaluation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>In vivo SpHb and PVi Monitoring</intervention_name>
    <description>Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)</description>
    <arm_group_label>Evaluation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing major surgeries associated with possibility of significant&#xD;
             blood loss (e.g. such that blood is cross-matched and available before the start of&#xD;
             the case as per hospital routine practice) under general anesthesia.&#xD;
&#xD;
          -  At least one finger available and accessible for performing non-invasive hemoglobin&#xD;
             monitoring.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has skin abnormalities affecting the digits such as psoriasis, eczema,&#xD;
             angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish&#xD;
             or acrylic nails that would prevent the proper fit and application of the sensors&#xD;
&#xD;
          -  Procedures performed using robotics surgery&#xD;
&#xD;
          -  Any patients with a known hemoglobinopathy&#xD;
&#xD;
          -  Any patients undergoing Cardio-Pulmonary Bypass (CPB)&#xD;
&#xD;
          -  Any patients who cannot be transfused or has refused consent for a blood transfusion&#xD;
&#xD;
          -  Patients being treated by any artificial oxygen carriers within 30 days of hospital&#xD;
             stay&#xD;
&#xD;
          -  Patients being managed outside of an operating room in the participating centers, or&#xD;
             in operating room with conditions not conducive to perform and complete the study&#xD;
             procedures (including use of the hemoglobin monitoring device)&#xD;
&#xD;
          -  Patients younger than 18 years old&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Patients with cardiac arrhythmia&#xD;
&#xD;
          -  Patients with tidal volume setting &lt; 6ml/kg&#xD;
&#xD;
          -  Patients with PEEP &gt;= 10cm H2O&#xD;
&#xD;
          -  Patients undergoing cardiac and/or any open chest procedures&#xD;
&#xD;
          -  Emergency patients due to the foreseeable difficulty in consenting&#xD;
&#xD;
          -  Patients deemed not suitable for study at the discretion of the Principal Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>September 16, 2021</results_first_submitted>
  <results_first_submitted_qc>December 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 5, 2022</results_first_posted>
  <disposition_first_submitted>September 18, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>September 18, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 5, 2022</disposition_first_posted>
  <last_update_submitted>December 10, 2021</last_update_submitted>
  <last_update_submitted_qc>December 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT02986789/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>Clinicians will be performing blood transfusions using hospital standard of care procedures.</description>
        </group>
        <group group_id="P2">
          <title>Evaluation Group</title>
          <description>Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.&#xD;
In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="0"/>
              </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>
      <population>No participants enrolled in the evaluation group.</population>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>Clinicians will be performing blood transfusions using hospital standard of care procedures.</description>
        </group>
        <group group_id="B2">
          <title>Evaluation Group</title>
          <description>Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.&#xD;
In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)</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="43"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="14"/>
                  </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="22"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic, Latino, or Spanish origin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White or Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Volume of Allogenic RBC Transfused Intra-operatively</title>
        <description>Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.</description>
        <time_frame>Approximately 6-8 hours</time_frame>
        <population>Only historical chart review was able to be completed for the 43 control subjects, therefore there are no results to report for the control group. This study was not able to meet the enrollment target for the control and intervention groups, and therefore average volume of allogenic RBC transfused intra-operatively could not be defined (primary outcome measures).</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Clinicians will be performing blood transfusions using hospital standard of care procedures.</description>
          </group>
          <group group_id="O2">
            <title>Evaluation Group</title>
            <description>Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.&#xD;
In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)</description>
          </group>
        </group_list>
        <measure>
          <title>Average Volume of Allogenic RBC Transfused Intra-operatively</title>
          <description>Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.</description>
          <population>Only historical chart review was able to be completed for the 43 control subjects, therefore there are no results to report for the control group. This study was not able to meet the enrollment target for the control and intervention groups, and therefore average volume of allogenic RBC transfused intra-operatively could not be defined (primary outcome measures).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>No participations were enrolled in the evaluation group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>Clinicians will be performing blood transfusions using hospital standard of care procedures.</description>
        </group>
        <group group_id="E2">
          <title>Evaluation Group</title>
          <description>Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.&#xD;
In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)</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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Cristina Johnson</name_or_title>
      <organization>Masimo Corporation</organization>
      <phone>949-297-7000</phone>
      <email>clinicalresearchdept@masimo.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/NCT02986789
org study id: BIGT0001
nct id: NCT02986789
lead sponsor: 
is unapproved device: Yes
The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring
      using pulse-oximetry based technologies and their effect on the management of transfusion and
      infusion decisions and clinical outcomes for the surgical patient.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: None (Open Label)
measure: Average Volume of Allogenic RBC Transfused Intra-operatively
time frame: Approximately 6-8 hours
description: Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.
arm group label: Control Group
arm group type: No Intervention
description: Clinicians will be performing blood transfusions using hospital standard of care procedures.
arm group label: Evaluation Group
arm group type: Experimental
description: Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.
intervention type: Device
intervention name: In vivo SpHb and PVi Monitoring
description: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)
arm group label: Evaluation Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 