Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.

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

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."

Study Overview

• Status: Terminated
• Conditions: Cardiac Output

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • New York
    • Elmira, New York, United States, 14905
      • Arnot Ogden Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Transonic Systems Inc.
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Nikolai Krivitski, PhD, DSc, Transonic Systems Inc.; Principal Investigator: Edward P Nast, MD, Arnot Ogden Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 15, 2010

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; cardiac output; ultrasound dilution
• Other Study ID Numbers: TSI-C-HCE101-4A-H; 2R44HL082022-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO