Recirculation, Oxygenator Blood Volume and Cardiac Output Measurements During Extracorporeal Membrane Oxygenation

NCT ID: NCT00920569

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

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-08-31

Brief Summary

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This study is to test the usefulness of ultrasound dilution measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). At the present time there are no devices available to perform these functions.

Detailed Description

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At the present time there are no devices available to measure recirculation, oxygenator blood volume and cardiac output in patients on extracorporeal membrane oxygenation. The study uses an external monitor, laptop computer, clamp on flowsensors and ultrasound dilution technology to measure blood flow. Measurements are made by injecting 0.5 - 1 ml/kg of sterile isotonic saline into the patient's extracorporeal circuit. The subject will be monitored throughout the measurements. The measurements will be coordinated with the regular care of the extracorporeal circuit.

Conditions

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Recirculation Oxygenator Blood Volume Cardiac Output Venoarterial Extracorporeal Membrane Oxygenation Venovenous Extracorporeal Membrane Oxygenation

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Neonatal, pediatric or adult patients receiving venoarterial or venovenous extracorporeal membrane oxygenation.

Exclusion Criteria

* Patients not receiving venoarterial or venovenous extracorporeal membrane oxygenation.
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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Jonathan Haft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Nikolai M Krivitski, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

Transonic Systems Inc.

Locations

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University of Michigan, Medical School

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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1R43HL082022-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TSI-G-HCE101-2A-H

Identifier Type: -

Identifier Source: org_study_id

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