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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by University of California, Los Angeles.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883857
First Posted: April 20, 2009
Last Update Posted: April 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, Los Angeles
  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

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

Estimated Enrollment: 100
Study Start Date: October 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Aman Mahajan, MD, PhD, UCLA
ClinicalTrials.gov Identifier: NCT00883857     History of Changes
Other Study ID Numbers: 06-04-090-03
First Submitted: April 17, 2009
First Posted: April 20, 2009
Last Update Posted: April 20, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases