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NCT01103908 Clinical Trial

Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

Cardiac Output Clinical Trial

Official title:
Ultrasound Dilution Cardiac Output at the Conclusion of Cardiopulmonary Bypass in Pediatric Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01103908
Other study ID # TSI-G-HCE101-5A-H
Secondary ID 2R44HL082022-02
Status Terminated
Phase N/A
First received April 13, 2010
Last updated May 25, 2016
Start date April 2010
Est. completion date August 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

Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date August 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Pediatric patients (age < 21 years)

- Pediatric patients undergoing surgery involving cardiopulmonary bypass

Exclusion Criteria:

- Patients aged > 21 years

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• HCE101 Cardiopulmonary Support Monitor
Measurement of cardiac output using ultrasound dilution technology. The ultrasound dilution technology is in the HCE101 Cardiopulmonary Support Monitor.

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

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 in pediatric patients after undergoing surgery involving cardiopulmonary bypass Less than 10 minutes No
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