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NCT00851422 Clinical Trial

Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique

Cardiac Output Clinical Trial

— BCM  

Official title:
Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00851422
Other study ID # TSI-C-COSTATUS-5A-H
Secondary ID 2R44HL061994-04A
Status Completed
Phase Phase 2/Phase 3
First received February 25, 2009
Last updated May 30, 2012
Start date February 2008
Est. completion date May 2011

Study information
Verified date May 2012
Source Transonic Systems Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Texas Children's Hospital Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
Transonic Systems Inc. National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Crittendon I 3rd, Dreyer WJ, Decker JA, Kim JJ. Ultrasound dilution: an accurate means of determining cardiac output in children. Pediatr Crit Care Med. 2012 Jan;13(1):42-6. doi: 10.1097/PCC.0b013e3182196804. — View Citation

Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution. 5-8 minutes minimum No
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