Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass
Terminated
- Conditions
- Cardiac Output
- Interventions
- Device: HCE101 Cardiopulmonary Support Monitor
- Registration Number
- NCT01103908
- Lead Sponsor
- Transonic Systems Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric cardiac output (CO) after CPB HCE101 Cardiopulmonary Support Monitor Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.
- Primary Outcome Measures
Name Time Method Cardiac output after cardiopulmonary bypass Less than 10 minutes Cardiac output will be measured in pediatric patients after undergoing surgery involving cardiopulmonary bypass
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States