<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/NCT01678066</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001561</org_study_id>
    <nct_id>NCT01678066</nct_id>
  </id_info>
  <brief_title>A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor</brief_title>
  <official_title>A Prospective Study to Bilaterally Compare a New FDA-Approved Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate&#xD;
      information when placed on a patient's Right or Left side.&#xD;
&#xD;
      Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac&#xD;
      output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The&#xD;
      FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the&#xD;
      manufacturer in pediatric and adult patients with leads placed on the left side. However,&#xD;
      sometimes the surgical site and/or patient position precludes placement of the monitor leads&#xD;
      on the left side. In such situations it would be useful to know whether placement of the&#xD;
      monitor's leads on a patient's right side gives accurate cardiac output data. We will&#xD;
      prospectively collect, and compare, simultaneous physiologic data for all enrolled children&#xD;
      using two monitors, one on the patient's right side and one on the patient's left side.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditionally cardiac output has been estimated with thermodilution, Fick oxygen consumption&#xD;
      or with echocardiography. Other non-invasive techniques such as analysis of arterial wave&#xD;
      forms and measurement of expired carbon dioxide have been attempted but with variable&#xD;
      success. Recently a new device (Cardiotronic® EC™) has been approved by the FDA for use in&#xD;
      children of all ages including neonates. Electrical cardiometry is a new method which can&#xD;
      continuously estimate stroke volume and left ventricular outflow to calculate cardiac output,&#xD;
      calculate cardiac index, as well as a variety of other parameters through quantitation of&#xD;
      changes in impedance associated with changes in the orientation of red blood cells. During&#xD;
      diastole red cells are organized chaotically but during systole they assume a position&#xD;
      parallel to the direction of blood flow. Thus thoracic electrical bioimpedance relate to&#xD;
      changes in thoracic aortic blood flow and through the use of refined algorithms non-invasive&#xD;
      measurement of cardiac output is achieved.&#xD;
&#xD;
      The height (cm), gender, weight (kg) and age of the patient are entered into the hand-held&#xD;
      device. Eight electrodes are applied to the neck and chest at specified locations, four per&#xD;
      device. The device records the heart rate and averages cardiac output every 10-60 heartbeats&#xD;
      again depending upon how the device is configured.&#xD;
&#xD;
      This is a prospective, non-randomized study to collect data from two noninvasive FDA-approved&#xD;
      cardiac output monitors simultaneously in pediatric patients under general anesthesia in the&#xD;
      operating room from age 1 month old to 8 years old with all types of medical conditions. We&#xD;
      will enroll 50 male and female pediatric patients who are having lower abdominal and lower&#xD;
      extremity surgery in this study so that the additional 8 EKG leads placed on the patients do&#xD;
      not interfere with the surgical site or patient positioning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">February 2013</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bilateral cardiac output using the Cardiotronic ICON non-invasive cardiac output monitor.</measure>
    <time_frame>6 months</time_frame>
    <description>To simultaneously compare physiologic data collected from two non-invasive cardiac output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the manufacturer in pediatric and adult patients with leads placed on the left side. However, sometimes the surgical site and/or patient position precludes placement of the monitor leads on the left side. In such situations it would be useful to know whether placement of the monitor's leads on a patient's right side gives accurate cardiac output data. We will prospectively collect, and compare, simultaneous physiologic data for all enrolled children using two monitors, one on the patient's right side and one on the patient's left side.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Anesthesiology</condition>
  <condition>Pediatrics</condition>
  <condition>General Surgery</condition>
  <condition>Orthopedics</condition>
  <condition>General Anesthesia</condition>
  <condition>Cardiac Output</condition>
  <arm_group>
    <arm_group_label>Bilateral cardiac output</arm_group_label>
    <description>This is a prospective, non-randomized study to collect data from two noninvasive FDA-approved cardiac output monitors simultaneously in pediatric patients under general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions. We will enroll 50 male and female pediatric patients who are having lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads placed on the patients do not interfere with the surgical site or patient positioning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bilateral cardiac output</intervention_name>
    <arm_group_label>Bilateral cardiac output</arm_group_label>
    <other_name>Cardiotronic ICON non-invasive cardiac output monitor</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients who will undergo general anesthesia in the operating room from age 1&#xD;
        month old to 8 years old with all types of medical conditions who are having lower&#xD;
        abdominal and lower extremity surgery in this study so that the additional 8 EKG leads&#xD;
        placed on the patients do not interfere with the surgical site or patient positioning.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1 month old to 8 years old.&#xD;
&#xD;
          -  Lower abdominal or lower extremity surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 1 month old.&#xD;
&#xD;
          -  Greater than 8 years old.&#xD;
&#xD;
          -  Patients undergoing upper abdominal, thoracic, upper extremity, or head/neck surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas A Anderson, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas A Anderson, PhD, MD</last_name>
    <phone>617-724-7247</phone>
    <email>tanderson9@partners.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Charles J Cote, MD</last_name>
    <phone>617-724-2250</phone>
    <email>cjcote@partners.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Thomas A Anderson, PhD, MD</last_name>
      <phone>617-724-7247</phone>
      <email>tanderson9@partners.org</email>
    </contact>
    <contact_backup>
      <last_name>Charles J Cote, MD</last_name>
      <phone>617-724-2250</phone>
      <email>cjcote@partners.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Suttner S, Schollhorn T, Boldt J, Mayer J, Rohm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. doi: 10.1007/s00134-006-0409-x. Epub 2006 Oct 13.</citation>
    <PMID>17039348</PMID>
  </reference>
  <reference>
    <citation>Norozi K, Beck C, Osthaus WA, Wille I, Wessel A, Bertram H. Electrical velocimetry for measuring cardiac output in children with congenital heart disease. Br J Anaesth. 2008 Jan;100(1):88-94. doi: 10.1093/bja/aem320. Epub 2007 Nov 16.</citation>
    <PMID>18024954</PMID>
  </reference>
  <reference>
    <citation>Zoremba N, Bickenbach J, Krauss B, Rossaint R, Kuhlen R, Schalte G. Comparison of electrical velocimetry and thermodilution techniques for the measurement of cardiac output. Acta Anaesthesiol Scand. 2007 Nov;51(10):1314-9. doi: 10.1111/j.1399-6576.2007.01445.x.</citation>
    <PMID>17944633</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Thomas Anthony Anderson</investigator_full_name>
    <investigator_title>Assistant in Anesthesia</investigator_title>
  </responsible_party>
  <keyword>Noninvasive cardiac output.</keyword>
  <keyword>Pediatrics.</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/NCT01678066
org study id: 2012P001561
nct id: NCT01678066
lead sponsor: 
has dmc: No
Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate
      information when placed on a patient's Right or Left side.

      Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac
      output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The
      FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the
      manufacturer in pediatric and adult patients with leads placed on the left side. However,
      sometimes the surgical site and/or patient position precludes placement of the monitor leads
      on the left side. In such situations it would be useful to know whether placement of the
      monitor's leads on a patient's right side gives accurate cardiac output data. We will
      prospectively collect, and compare, simultaneous physiologic data for all enrolled children
      using two monitors, one on the patient's right side and one on the patient's left side.
Traditionally cardiac output has been estimated with thermodilution, Fick oxygen consumption
      or with echocardiography. Other non-invasive techniques such as analysis of arterial wave
      forms and measurement of expired carbon dioxide have been attempted but with variable
      success. Recently a new device (Cardiotronic® EC™) has been approved by the FDA for use in
      children of all ages including neonates. Electrical cardiometry is a new method which can
      continuously estimate stroke volume and left ventricular outflow to calculate cardiac output,
      calculate cardiac index, as well as a variety of other parameters through quantitation of
      changes in impedance associated with changes in the orientation of red blood cells. During
      diastole red cells are organized chaotically but during systole they assume a position
      parallel to the direction of blood flow. Thus thoracic electrical bioimpedance relate to
      changes in thoracic aortic blood flow and through the use of refined algorithms non-invasive
      measurement of cardiac output is achieved.

      The height (cm), gender, weight (kg) and age of the patient are entered into the hand-held
      device. Eight electrodes are applied to the neck and chest at specified locations, four per
      device. The device records the heart rate and averages cardiac output every 10-60 heartbeats
      again depending upon how the device is configured.

      This is a prospective, non-randomized study to collect data from two noninvasive FDA-approved
      cardiac output monitors simultaneously in pediatric patients under general anesthesia in the
      operating room from age 1 month old to 8 years old with all types of medical conditions. We
      will enroll 50 male and female pediatric patients who are having lower abdominal and lower
      extremity surgery in this study so that the additional 8 EKG leads placed on the patients do
      not interfere with the surgical site or patient positioning.
observational model: Cohort
time perspective: Prospective
measure: Bilateral cardiac output using the Cardiotronic ICON non-invasive cardiac output monitor.
time frame: 6 months
description: To simultaneously compare physiologic data collected from two non-invasive cardiac output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the manufacturer in pediatric and adult patients with leads placed on the left side. However, sometimes the surgical site and/or patient position precludes placement of the monitor leads on the left side. In such situations it would be useful to know whether placement of the monitor's leads on a patient's right side gives accurate cardiac output data. We will prospectively collect, and compare, simultaneous physiologic data for all enrolled children using two monitors, one on the patient's right side and one on the patient's left side.
arm group label: Bilateral cardiac output
description: This is a prospective, non-randomized study to collect data from two noninvasive FDA-approved cardiac output monitors simultaneously in pediatric patients under general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions. We will enroll 50 male and female pediatric patients who are having lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads placed on the patients do not interfere with the surgical site or patient positioning.
intervention type: Device
intervention name: Bilateral cardiac output
arm group label: Bilateral cardiac output
other name: Cardiotronic ICON non-invasive cardiac output monitor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 8 Years
healthy volunteers: No
last name: Thomas A Anderson, PhD, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Thomas A Anderson, PhD, MD
phone: 617-724-7247
email: tanderson9@partners.org
last name: Charles J Cote, MD
phone: 617-724-2250
email: cjcote@partners.org
facility: 
contact: 
contact backup: 
country: United States
citation: Suttner S, Schollhorn T, Boldt J, Mayer J, Rohm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. doi: 10.1007/s00134-006-0409-x. Epub 2006 Oct 13.
PMID: 17039348
citation: Norozi K, Beck C, Osthaus WA, Wille I, Wessel A, Bertram H. Electrical velocimetry for measuring cardiac output in children with congenital heart disease. Br J Anaesth. 2008 Jan;100(1):88-94. doi: 10.1093/bja/aem320. Epub 2007 Nov 16.
PMID: 18024954
citation: Zoremba N, Bickenbach J, Krauss B, Rossaint R, Kuhlen R, Schalte G. Comparison of electrical velocimetry and thermodilution techniques for the measurement of cardiac output. Acta Anaesthesiol Scand. 2007 Nov;51(10):1314-9. doi: 10.1111/j.1399-6576.2007.01445.x.
PMID: 17944633
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Thomas Anthony Anderson
investigator title: Assistant in Anesthesia