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Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01103908
Enrollment
3
Registered
2010-04-15
Start date
2010-04-30
Completion date
2011-08-31
Last updated
2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output

Keywords

cardiac output, cardiopulmonary bypass, ultrasound dilution

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.

Interventions

DEVICEHCE101 Cardiopulmonary Support Monitor

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Transonic Systems Inc.
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output after cardiopulmonary bypassLess than 10 minutesCardiac output will be measured in pediatric patients after undergoing surgery involving cardiopulmonary bypass

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026