Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

Transonic Systems

Status: Terminated

Conditions: Cardiac Output

Treatments: Device: HCE101 Cardiopulmonary Support Monitor

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01103908

2R44HL082022-02 (U.S. NIH Grant/Contract)

TSI-G-HCE101-5A-H

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

3 participants in 1 patient group

Pediatric cardiac output (CO) after CPB

Description:

Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.

Treatment:

Device: HCE101 Cardiopulmonary Support Monitor