Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

NCT ID: NCT01103908

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Cardiac Output

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric cardiac output (CO) after CPB

Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.

HCE101 Cardiopulmonary Support Monitor

Intervention Type DEVICE

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

Interventions

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HCE101 Cardiopulmonary Support Monitor

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Transonic Systems Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikolai Krivitski, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

Transonic Systems Inc.

Alistair Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2R44HL082022-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TSI-G-HCE101-5A-H

Identifier Type: -

Identifier Source: org_study_id

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