Comparison Endotracheal Cardiac Output Monitor (ECOM) to a Standard Device in Measuring Heart Blood Volume
1 other identifier
observational
49
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 17, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJune 12, 2018
June 1, 2018
3.1 years
April 17, 2009
June 8, 2018
Conditions
Eligibility Criteria
Patients scheduled for cardiac surgery
You may qualify if:
- Able to give informed consent
- Patients requiring all of the following:
- an oral ET tube
- an arterial catheter
- measurement of CO
You may not qualify if:
- Patients not competent to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aman Mahajan, MD, PhD
University of California, Los Angeles
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 17, 2009
First Posted
April 20, 2009
Study Start
October 1, 2007
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
June 12, 2018
Record last verified: 2018-06