Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.

Cardiac Output Clinical Trial

Official title:

Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass

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

• Cardiac Output

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