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Comparison Endotracheal Cardiac Output Monitor (ECOM) to a Standard Device in Measuring Heart Blood Volume

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00883857
First received: April 17, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

The purpose of this study is to evaluate a new monitor that measures cardiac output (amount of blood pumped by the heart). The system that is being tested in this study, called Endotracheal Cardiac Output Monitor (ECOM), uses electricity (impedance cardiography) to measure cardiac output and is not harmful to the patient.

This study will test the accuracy and efficacy of the ECOM system in anesthetized and sedated patients who, in the normal course of clinical care in the OR or ICU, are having cardiac output measured. The investigators propose that unlike the standard system for cardiac output measurement, the ConMed ECOM System should result in a simplified, inexpensive, continuous, less-invasive, and accurate method of measuring cardiac output. Such a technique could allow the rapid diagnosis of instability in the cardiovascular system for critically ill patients.


Condition
Heart Disease
Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Endotracheal Cardiac Output Monitor (ECOM) to a Standard Device in Measuring Heart Blood Volume

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Estimated Enrollment: 100
Study Start Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients scheduled for cardiac surgery

Criteria

Inclusion Criteria:

  • Able to give informed consent

  • Patients requiring all of the following:

    • an oral ET tube
    • an arterial catheter
    • measurement of CO

Exclusion Criteria:

  • Patients not competent to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883857

Contacts
Contact: Jennifer Corniea, MA 310-206-4484 jcorniea@mednet.ucla.edu
Contact: Aman Mahajan, MD, PhD 310-267-8680 amahajan@mednet.ucla.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Jennifer Corniea, MA     310-206-4484     jcorniea@mednet.ucla.edu    
Contact: Aman Mahajan, MD, PhD     310-267-8680     amahajan@mednet.ucla.edu    
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Study Director: Aman Mahajan, MD, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Aman Mahajan, MD, PhD, UCLA
ClinicalTrials.gov Identifier: NCT00883857     History of Changes
Other Study ID Numbers: 06-04-090-03
Study First Received: April 17, 2009
Last Updated: April 17, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013