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Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

NCT01103908 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2016-05-27

No results posted yet for this study

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.

Conditions

  • Cardiac Output

Interventions

DEVICE

HCE101 Cardiopulmonary Support Monitor

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Transonic Systems Inc.

    lead INDUSTRY

Principal Investigators

  • Nikolai Krivitski, PhD, DSc · Transonic Systems Inc.

  • Alistair Phillips, MD · Nationwide Children's Hospital

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103908 on ClinicalTrials.gov