<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/NCT02184169</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00006630</org_study_id>
    <nct_id>NCT02184169</nct_id>
  </id_info>
  <brief_title>Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)</brief_title>
  <acronym>Oxy-CAHN</acronym>
  <official_title>Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General Electric</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn&#xD;
      infants recovering from congenital heart surgery. Currently, we utilize important but&#xD;
      unsophisticated measures, such as vital signs and lactate measurements, to monitor these&#xD;
      patients. Although they are useful in categorizing patients as well or unwell, these signs&#xD;
      currently lack the power quantify a patient's risk for cardiac arrest. More to the point,&#xD;
      they are mostly indirect measures of what we really are assessing, which is tissue oxygen&#xD;
      delivery.&#xD;
&#xD;
      Our group has signiﬁcant expertise with devices which quantify the amount of oxygen that a&#xD;
      baby consumes every minute. Historically, these values are more commonly used in combination&#xD;
      with other measures to assess nutritional and metabolism status. In critically ill patients,&#xD;
      however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen&#xD;
      their circulation delivers. This may represent a critical relationship, which has been&#xD;
      previously described, but not exploited for the purpose of identifying patients with&#xD;
      critically low oxygen delivery.&#xD;
&#xD;
      The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely&#xD;
      and precisely measured continuously in newborns undergoing one of two common congenital heart&#xD;
      surgeries, (2) to determine whether postoperative circulatory failure is associated with a&#xD;
      precedent change in oxygen consumption, and (3) to determine whether the addition of the&#xD;
      oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to&#xD;
      standardly measured parameters will add power in predicting which patients will experience&#xD;
      postoperative circulatory failure.&#xD;
&#xD;
      If successful, this study may improve our capacity to non-invasively and continuously monitor&#xD;
      patients following the highest risk congenital heart surgeries, and in the future,to create&#xD;
      an algorithm which quantiﬁes a patients risk for having a cardiac arrest. This may permit&#xD;
      providers to intervene on these patients earlier, improving the morbidity and mortality&#xD;
      associated with congenital heart disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">January 29, 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen Consumption</measure>
    <time_frame>While mechanically ventilated, up to 14 days</time_frame>
    <description>Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Computed Cardiac Index</measure>
    <time_frame>While mechanically ventilated, up to 14 days</time_frame>
    <description>A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Transposition of the Great Vessels</condition>
  <condition>Hypoplastic Left Heart Syndrome</condition>
  <condition>Oxygen Consumption Based Assessment of Hemodynamics</condition>
  <arm_group>
    <arm_group_label>HLHS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing palliative repair.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TGA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical repair of TGA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments</intervention_name>
    <description>Breath to breath VO2 measurements</description>
    <arm_group_label>HLHS</arm_group_label>
    <arm_group_label>TGA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr</intervention_name>
    <description>Edwards continuous SVO2 measurement system</description>
    <arm_group_label>HLHS</arm_group_label>
    <arm_group_label>TGA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients from birth to 6 months of age&#xD;
&#xD;
          2. HLHS AND no prior operations AND planned S1P or HPOR d-TGA/IVS AND planned ASO&#xD;
&#xD;
          3. Written parental informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Weight &lt; 2 kg&#xD;
&#xD;
          2. Disease speciﬁc A. HLHS patients: Infants whose surgical plan includes a neonatal&#xD;
             biventricularrepair will be excluded.&#xD;
&#xD;
             B. d-TGA/IVS patients: Newborns with any additional cardiac defect other than an&#xD;
             atrial septal defect will be excluded.&#xD;
&#xD;
          3. Patients on ECMO preoperatively&#xD;
&#xD;
          4. Clinically signiﬁcant tracheo-esophageal ﬁstula or known preoperative air leak&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Kheir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Mills KI, Kaza AK, Walsh BK, Bond HC, Ford M, Wypij D, Thiagarajan RR, Almodovar MC, Quinonez LG, Baird CW, Emani SE, Pigula FA, DiNardo JA, Kheir JN. Phosphodiesterase Inhibitor-Based Vasodilation Improves Oxygen Delivery and Clinical Outcomes Following Stage 1 Palliation. J Am Heart Assoc. 2016 Nov 2;5(11):e003554. doi: 10.1161/JAHA.116.003554.</citation>
    <PMID>27806964</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>January 16, 2020</results_first_submitted>
  <results_first_submitted_qc>June 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2020</results_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>John Kheir</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>hemodynamics</keyword>
  <keyword>neonatal</keyword>
  <keyword>cardiac disease</keyword>
  <keyword>congenital heart disease</keyword>
  <keyword>volumetric oxygen consumption</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoplastic Left Heart Syndrome</mesh_term>
    <mesh_term>Transposition of Great Vessels</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 1, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT02184169/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>HLHS</title>
          <description>Patients undergoing palliative repair.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</description>
        </group>
        <group group_id="P2">
          <title>TGA With/Without VSD</title>
          <description>Surgical repair of TGA.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HLHS</title>
          <description>Patients undergoing palliative repair.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</description>
        </group>
        <group group_id="B2">
          <title>TGA/IVS</title>
          <description>Surgical repair of TGA.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</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="21"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 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>&gt;=65 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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value=".1" spread=".1"/>
                    <measurement group_id="B2" value=".1" spread=".1"/>
                    <measurement group_id="B3" value=".1" spread=".1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Region of surgery</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Oxygen Consumption</title>
        <description>Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.</description>
        <time_frame>While mechanically ventilated, up to 14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HLHS</title>
            <description>Patients undergoing palliative repair.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</description>
          </group>
          <group group_id="O2">
            <title>TGA With/Without VSD</title>
            <description>Surgical repair of TGA.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygen Consumption</title>
          <description>Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.</description>
          <units>mL oxygen/min/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="21"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" spread="12"/>
                    <measurement group_id="O2" value="102" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Computed Cardiac Index</title>
        <description>A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.</description>
        <time_frame>While mechanically ventilated, up to 14 days</time_frame>
        <population>The average cardiac index was measured for each patient twice per day</population>
        <group_list>
          <group group_id="O1">
            <title>Hypoplastic Left Heart Syndrome</title>
            <description>Patients undergoing palliative repair.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</description>
          </group>
          <group group_id="O2">
            <title>Transposition of the Great Arteries</title>
            <description>Surgical repair of TGA.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</description>
          </group>
        </group_list>
        <measure>
          <title>Computed Cardiac Index</title>
          <description>A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.</description>
          <population>The average cardiac index was measured for each patient twice per day</population>
          <units>L/min/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="0.4"/>
                    <measurement group_id="O2" value="2.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>HLHS</title>
          <description>Patients undergoing palliative repair.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</description>
        </group>
        <group group_id="E2">
          <title>TGA/IVS</title>
          <description>Surgical repair of TGA.&#xD;
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements&#xD;
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system</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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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>John Kheir</name_or_title>
      <organization>Boston Childrens Hospital</organization>
      <phone>6173556000</phone>
      <email>john.kheir@childrens.harvard.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/NCT02184169
org study id: IRB-P00006630
nct id: NCT02184169
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn
      infants recovering from congenital heart surgery. Currently, we utilize important but
      unsophisticated measures, such as vital signs and lactate measurements, to monitor these
      patients. Although they are useful in categorizing patients as well or unwell, these signs
      currently lack the power quantify a patient's risk for cardiac arrest. More to the point,
      they are mostly indirect measures of what we really are assessing, which is tissue oxygen
      delivery.

      Our group has signiﬁcant expertise with devices which quantify the amount of oxygen that a
      baby consumes every minute. Historically, these values are more commonly used in combination
      with other measures to assess nutritional and metabolism status. In critically ill patients,
      however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen
      their circulation delivers. This may represent a critical relationship, which has been
      previously described, but not exploited for the purpose of identifying patients with
      critically low oxygen delivery.

      The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely
      and precisely measured continuously in newborns undergoing one of two common congenital heart
      surgeries, (2) to determine whether postoperative circulatory failure is associated with a
      precedent change in oxygen consumption, and (3) to determine whether the addition of the
      oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to
      standardly measured parameters will add power in predicting which patients will experience
      postoperative circulatory failure.

      If successful, this study may improve our capacity to non-invasively and continuously monitor
      patients following the highest risk congenital heart surgeries, and in the future,to create
      an algorithm which quantiﬁes a patients risk for having a cardiac arrest. This may permit
      providers to intervene on these patients earlier, improving the morbidity and mortality
      associated with congenital heart disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Oxygen Consumption
time frame: While mechanically ventilated, up to 14 days
description: Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.
measure: Computed Cardiac Index
time frame: While mechanically ventilated, up to 14 days
description: A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.
arm group label: HLHS
arm group type: Experimental
description: Patients undergoing palliative repair.
arm group label: TGA
arm group type: Active Comparator
description: Surgical repair of TGA.
intervention type: Device
intervention name: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments
description: Breath to breath VO2 measurements
arm group label: HLHS
arm group label: TGA
intervention type: Device
intervention name: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr
description: Edwards continuous SVO2 measurement system
arm group label: HLHS
arm group label: TGA
criteria: 
gender: All
minimum age: 1 Day
maximum age: 6 Months
healthy volunteers: No
last name: John Kheir, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
citation: Mills KI, Kaza AK, Walsh BK, Bond HC, Ford M, Wypij D, Thiagarajan RR, Almodovar MC, Quinonez LG, Baird CW, Emani SE, Pigula FA, DiNardo JA, Kheir JN. Phosphodiesterase Inhibitor-Based Vasodilation Improves Oxygen Delivery and Clinical Outcomes Following Stage 1 Palliation. J Am Heart Assoc. 2016 Nov 2;5(11):e003554. doi: 10.1161/JAHA.116.003554.
PMID: 27806964
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: John Kheir
investigator title: PI
mesh term: Hypoplastic Left Heart Syndrome
mesh term: Transposition of Great Vessels
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 