<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/NCT01662141</url>
  </required_header>
  <id_info>
    <org_study_id>TSI-S-COstatus-13A-H</org_study_id>
    <secondary_id>IRB</secondary_id>
    <nct_id>NCT01662141</nct_id>
  </id_info>
  <brief_title>Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children</brief_title>
  <official_title>Investigation of the Reliability to Measure Cardiac Output by a New Ultrasound Dilution Method in Mechanically Ventilated Children After Pediatric Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Transonic Systems Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Transonic Systems Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper&#xD;
      management of severely hemodynamic compromised patients. A new ultrasound dilution method&#xD;
      (COstatus) for cardiac output measurement has been developed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The thermodilution technique with a pulmonary artery catheter has been the standard in adult&#xD;
      patients for cardiac output measurement. However, using pulmonary artery catheter remains a&#xD;
      major clinical problem in children due to technical and size constraints.&#xD;
&#xD;
      COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by&#xD;
      body-temperature isotonic saline injected into the central vein and calculates cardiac output&#xD;
      derived from a dilution curve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.</measure>
    <time_frame>Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.</time_frame>
    <description>To compare cardiac outputs measured with this new ultrasound dilution method with flowmetry (perivascular probe) using ultrasound transit time measured directly on the aorta in children &lt; 15 kg of weight. Also to assess reliability of COstatus measurements in pediatric patients.</description>
  </primary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>Post Cardiac Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric Patients (&lt; 15) in the ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children &lt;15 kg admitted to pediatric cardiac surgery for corrective surgery and&#xD;
             mechanically ventilated were eligible for the study if parents provided informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with known significant tricuspid or mitral valve regurgitations or if it is&#xD;
             detected by the preoperative transesophageal echocardiographic examination.&#xD;
&#xD;
          -  Children with persistent severe arrhythmias.&#xD;
&#xD;
          -  Children with remaining intracardiac shunts after surgery, which may adversely affect&#xD;
             the measurement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Lindberg, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital in Lund</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children Hospital, BUS, BIVA</name>
      <address>
        <city>Lund</city>
        <zip>SE-221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.</citation>
    <PMID>18496416</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac output</keyword>
  <keyword>Perivascular Probe</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/NCT01662141
org study id: TSI-S-COstatus-13A-H
secondary id: IRB
nct id: NCT01662141
lead sponsor: 
has dmc: No
The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper
      management of severely hemodynamic compromised patients. A new ultrasound dilution method
      (COstatus) for cardiac output measurement has been developed.
The thermodilution technique with a pulmonary artery catheter has been the standard in adult
      patients for cardiac output measurement. However, using pulmonary artery catheter remains a
      major clinical problem in children due to technical and size constraints.

      COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by
      body-temperature isotonic saline injected into the central vein and calculates cardiac output
      derived from a dilution curve.
time perspective: Prospective
measure: Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.
time frame: Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.
description: To compare cardiac outputs measured with this new ultrasound dilution method with flowmetry (perivascular probe) using ultrasound transit time measured directly on the aorta in children < 15 kg of weight. Also to assess reliability of COstatus measurements in pediatric patients.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Lars Lindberg, MD, PhD
role: Principal Investigator
affiliation: University Hospital in Lund
facility: 
country: Sweden
citation: Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
PMID: 18496416
responsible party type: Sponsor