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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00853437
Other study ID # TSI-G-COSTATUS-2A-H
Secondary ID 2R44HL061994-04A
Status Completed
Phase N/A
First received February 27, 2009
Last updated May 25, 2016
Start date January 2009
Est. completion date May 2011

Study information

Verified date May 2016
Source Transonic Systems Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 16 Years
Eligibility Inclusion Criteria:

- Patients with in situ central venous and arterial catheters

- Ability to draw blood from arterial and central venous catheters

- Presence of parent or guardian to provide consent

Exclusion Criteria:

- Patients over 16 years of age.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Golisano Children's Hospital Rochester New York

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 (1)

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 Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference. 5-8 minutes minimum No
Secondary Measure blood volumes to compare effects of volume infusion and furosemide. 5-8 minutes minimum No
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