BCM: Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique
Sponsor
Transonic Systems Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00851422
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
28
1
38.9
0.7
Study Details
Study Description
Brief Summary
Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be problematic. Ultrasound dilution measurement has been shown to correlate with measured cardiac output in animal models and adults, but it has not been validated in pediatric patients. This study will validate the accuracy of ultrasound dilution measurements of cardiac output to thermodilution measurements of cardiac output in pediatric patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Study Type:
Observational
Actual Enrollment
:
28 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique
Study Start Date
:
Feb 1, 2008
Actual Primary Completion Date
:
May 1, 2011
Actual Study Completion Date
:
May 1, 2011
Outcome Measures
Primary Outcome Measures
- Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution. [5-8 minutes minimum]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Transplant patients undergoing hemodynamic evaluation in the catheterization laboratory that are less than 18 years of age and have structurally normal hearts.
Exclusion Criteria:
- Patient's age greater than 18 years, and any structural abnormality of the heart.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Children's Hospital | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Transonic Systems Inc.
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Jeffery J Kim, MD, Texas Children's Hospital, Baylor College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00851422
Other Study ID Numbers:
- TSI-C-COSTATUS-5A-H
- 2R44HL061994-04A2
First Posted:
Feb 26, 2009
Last Update Posted:
May 31, 2012
Last Verified:
May 1, 2012
Keywords provided by Transonic Systems Inc.