Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Ultrasound Dilution Cardiac Output at the Conclusion of Cardiopulmonary Bypass in Pediatric Patients|
- Cardiac output after cardiopulmonary bypass [ Time Frame: Less than 10 minutes ] [ Designated as safety issue: No ]Cardiac output will be measured in pediatric patients after undergoing surgery involving cardiopulmonary bypass
|Study Start Date:||April 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Pediatric cardiac output (CO) after CPB
Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.
Device: HCE101 Cardiopulmonary Support Monitor
Measurement of cardiac output using ultrasound dilution technology.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103908
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Nikolai Krivitski, PhD, DSc||Transonic Systems Inc.|
|Principal Investigator:||Alistair Phillips, MD||Nationwide Children's Hospital|