<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/NCT04465370</url>
  </required_header>
  <id_info>
    <org_study_id>2019-08</org_study_id>
    <nct_id>NCT04465370</nct_id>
  </id_info>
  <brief_title>Pediatric Cardiac Output Monitoring Observational Study</brief_title>
  <acronym>POGO</acronym>
  <official_title>A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight&#xD;
      system to intermittent thermodilution Swan-Ganz, in order to expand the indications of&#xD;
      FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric&#xD;
      population 12 to 18 years of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Actual">January 5, 2023</completion_date>
  <primary_completion_date type="Actual">January 5, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstration of monitoring cardiac output with Swan-Ganz, FloTrac, and ClearSight system</measure>
    <time_frame>Duration of the procedure through 30 days after procedure, plus or minus 14 days</time_frame>
    <description>Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Bland-Altman method of bias.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Critchley and Critchley method of percent error calculation.</measure>
    <time_frame>Duration of the procedure through 30 days after procedure, plus or minus 14 days</time_frame>
    <description>Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Critchley and Critchley method of percent error calculation.</description>
  </secondary_outcome>
  <enrollment type="Actual">89</enrollment>
  <condition>Pediatric ALL</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight</intervention_name>
    <description>A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Males and Females, 12 to 18 years of age at the time of screening. Who presenting to&#xD;
        Cardiac Catheterization Lab for right heart catheterizations.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are 12 to 18 years of age&#xD;
&#xD;
          -  Subjects who have signed the Informed Consent Form&#xD;
&#xD;
          -  Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard&#xD;
             of care with intermittent cardiac output measures&#xD;
&#xD;
          -  For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks&#xD;
             post cardiac transplantation&#xD;
&#xD;
          -  Subjects with planned pressure monitoring with an arterial line&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with contraindications for Pulmonary Artery Catheters Placement and&#xD;
             monitoring (recurrent sepsis, or with hypercoagulopathy);&#xD;
&#xD;
          -  Subjects with contraindications for Arterial Line Placement;&#xD;
&#xD;
          -  Subjects with an extreme contraction of the smooth muscle in the arteries and&#xD;
             arterioles in the lower arm and hand (i.e., Raynaud's Disease).&#xD;
&#xD;
          -  Subjects with a physical site area too limited for proper Sensor placement&#xD;
&#xD;
          -  Subjects with finger size less than the smallest finger cuff size&#xD;
&#xD;
          -  Documented ≥ moderate pulmonary hypertension (PAPm &gt; 25mmHg, PVRI &gt; 3.0 WUxm2)&#xD;
&#xD;
          -  Presence of intracardiac shunting (i.e., ASD, VSD)&#xD;
&#xD;
          -  Aorto-pulmonary collaterals&#xD;
&#xD;
          -  ≥ Moderate tricuspid regurgitation, per echocardiogram criteria&#xD;
&#xD;
          -  &gt; Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria&#xD;
&#xD;
          -  Persistent cardiac arrythmias during the cardiac catheterization period (&gt; 3min)&#xD;
&#xD;
          -  Vascular abnormalities of the arterial system (i.e., connective tissue disorders,&#xD;
             mid-aortic syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UF Health Shands Children's Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemodynamic Monitoring</keyword>
  <keyword>Cardiac Output</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04465370
org study id: 2019-08
nct id: NCT04465370
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight
      system to intermittent thermodilution Swan-Ganz, in order to expand the indications of
      FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric
      population 12 to 18 years of age.
observational model: Case-Only
time perspective: Prospective
measure: Demonstration of monitoring cardiac output with Swan-Ganz, FloTrac, and ClearSight system
time frame: Duration of the procedure through 30 days after procedure, plus or minus 14 days
description: Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Bland-Altman method of bias.
measure: Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Critchley and Critchley method of percent error calculation.
time frame: Duration of the procedure through 30 days after procedure, plus or minus 14 days
description: Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Critchley and Critchley method of percent error calculation.
intervention type: Device
intervention name: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
description: A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor