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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01103895
Other study ID # TSI-C-HCE101-4A-H
Secondary ID 2R44HL082022-02
Status Terminated
Phase N/A
First received April 13, 2010
Last updated May 25, 2016
Start date July 2007
Est. completion date May 2012

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

Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Patients aged > 21 years

- Patients undergoing surgery involving cardiopulmonary bypass

- Patients instrumented with a thermodilution catheter

Exclusion Criteria:

- Patients aged < 21 years

- Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Arnot Ogden Medical Center Elmira 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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac output after cardiopulmonary bypass Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass. Less than 10 minutes No
Secondary Cardiac output before cardiopulmonary bypass Cardiac output will be measured using an ultrasound dilution technique and compared to cardiac output measured using thermodilution. This will serve as a baseline measurement of the patient's cardiac output. Less than 10 minutes No
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