<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/NCT03757312</url>
  </required_header>
  <id_info>
    <org_study_id>IRB18-01209</org_study_id>
    <nct_id>NCT03757312</nct_id>
  </id_info>
  <brief_title>A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass</brief_title>
  <official_title>A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marco Corridore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the proposed study is to evaluate the incidence of subtle increases in&#xD;
      intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath&#xD;
      diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not&#xD;
      feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be&#xD;
      effective in the ICU and emergency room setting for detecting increased ICP and is an&#xD;
      accepted standard for such measurements. The primary hypothesis is that changes in ICP occur&#xD;
      following CPB without clinically appreciable signs and symptoms. These changes in ICP will be&#xD;
      reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral&#xD;
      edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic&#xD;
      and ventilation goals and techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2019</start_date>
  <completion_date type="Actual">January 16, 2020</completion_date>
  <primary_completion_date type="Actual">January 16, 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Optic Nerve Sheath Diameter</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Optic nerve sheath diameter normal values: ≤4.0 mm for patients &lt;1 year and ≤4.5 mm used for patients ≥1 year of age, thus there is potential for worse outcomes with higher diameters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Short CPB time defined as &lt;100 minutes. Long CPB time defined as ≥ 100 minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Congenital Heart Disease</condition>
  <condition>Congenital Heart Defect</condition>
  <arm_group>
    <arm_group_label>Fontan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Fontan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ocular ultrasound to measure optic nerve sheath diameter (ONSD).</description>
    <arm_group_label>Fontan</arm_group_label>
    <arm_group_label>Non-Fontan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years of age undergoing cardiac bypass.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Corridore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>August 16, 2021</results_first_submitted>
  <results_first_submitted_qc>September 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2021</results_first_posted>
  <last_update_submitted>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Marco Corridore</investigator_full_name>
    <investigator_title>Associate Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>cardiopulmonary bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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>December 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03757312/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fontan</title>
          <description>Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.&#xD;
Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD).</description>
        </group>
        <group group_id="P2">
          <title>Non-Fontan</title>
          <description>Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
              </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>Fontan</title>
          <description>Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.&#xD;
Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD).</description>
        </group>
        <group group_id="B2">
          <title>Non-Fontan</title>
          <description>Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.</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="5"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="14"/>
          </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="5"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </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>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.6" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B2" value="1.3" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="B3" value="1.8" lower_limit="0" upper_limit="6"/>
                  </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="5"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.5" lower_limit="7.9" upper_limit="16.6"/>
                    <measurement group_id="B2" value="9.3" lower_limit="3.7" upper_limit="20.2"/>
                    <measurement group_id="B3" value="10.8" lower_limit="3.7" upper_limit="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88.2" lower_limit="63" upper_limit="97.1"/>
                    <measurement group_id="B2" value="74.3" lower_limit="53" upper_limit="114.6"/>
                    <measurement group_id="B3" value="79.2" lower_limit="53" upper_limit="114.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Society of Anesthesiologists (ASA) status</title>
          <description>ASA 1 - normal healthy patient, ASA 2 - mild disease, ASA 3 - severe systemic disease, ASA 4 - severe systemic disease that is a constant threat to life</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>ASA 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASA 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Optic Nerve Sheath Diameter</title>
        <description>Optic nerve sheath diameter normal values: ≤4.0 mm for patients &lt;1 year and ≤4.5 mm used for patients ≥1 year of age, thus there is potential for worse outcomes with higher diameters.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fontan</title>
            <description>Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.&#xD;
Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD).</description>
          </group>
          <group group_id="O2">
            <title>Non-Fontan</title>
            <description>Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.</description>
          </group>
        </group_list>
        <measure>
          <title>Optic Nerve Sheath Diameter</title>
          <description>Optic nerve sheath diameter normal values: ≤4.0 mm for patients &lt;1 year and ≤4.5 mm used for patients ≥1 year of age, thus there is potential for worse outcomes with higher diameters.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post induction of anesthesia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3" upper_limit="4.6"/>
                    <measurement group_id="O2" value="3.6" lower_limit="3.1" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After coming off of CPB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="3.5" upper_limit="5.1"/>
                    <measurement group_id="O2" value="3.5" lower_limit="3.1" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Following tracheal extubation in the OR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="3.2" upper_limit="5.3"/>
                    <measurement group_id="O2" value="3.7" lower_limit="3.0" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time</title>
        <description>Short CPB time defined as &lt;100 minutes. Long CPB time defined as ≥ 100 minutes.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Short CPB Time</title>
            <description>Short CPB time defined as &lt;100 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Long CPB Time</title>
            <description>Long CPB time defined as ≥ 100 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time</title>
          <description>Short CPB time defined as &lt;100 minutes. Long CPB time defined as ≥ 100 minutes.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-induction of anesthesia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="3.6" upper_limit="4.0"/>
                    <measurement group_id="O2" value="3.6" lower_limit="3.0" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After coming off of CPB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="3.5" upper_limit="3.9"/>
                    <measurement group_id="O2" value="3.8" lower_limit="3.1" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Following tracheal extubation in the OR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="3.5" upper_limit="4.3"/>
                    <measurement group_id="O2" value="3.8" lower_limit="3.0" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours post-op</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fontan</title>
          <description>Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.&#xD;
Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD).</description>
        </group>
        <group group_id="E2">
          <title>Non-Fontan</title>
          <description>Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </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>Marco Corridore, MD</name_or_title>
      <organization>Nationwide Children's Hospital</organization>
      <phone>614-722-4200</phone>
      <email>Marco.Corridore@nationwidechildrens.org</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/NCT03757312
org study id: IRB18-01209
nct id: NCT03757312
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of the proposed study is to evaluate the incidence of subtle increases in
      intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath
      diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not
      feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be
      effective in the ICU and emergency room setting for detecting increased ICP and is an
      accepted standard for such measurements. The primary hypothesis is that changes in ICP occur
      following CPB without clinically appreciable signs and symptoms. These changes in ICP will be
      reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral
      edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic
      and ventilation goals and techniques.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Optic Nerve Sheath Diameter
time frame: Day of surgery
description: Optic nerve sheath diameter normal values: ≤4.0 mm for patients <1 year and ≤4.5 mm used for patients ≥1 year of age, thus there is potential for worse outcomes with higher diameters.
measure: Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time
time frame: Day of surgery
description: Short CPB time defined as <100 minutes. Long CPB time defined as ≥ 100 minutes.
arm group label: Fontan
arm group type: Experimental
description: Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.
arm group label: Non-Fontan
arm group type: Active Comparator
description: Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
intervention type: Diagnostic Test
intervention name: Ultrasound
description: Ocular ultrasound to measure optic nerve sheath diameter (ONSD).
arm group label: Fontan
arm group label: Non-Fontan
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Marco Corridore, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Marco Corridore
investigator title: Associate Professor of Anesthesiology
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 