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

May 25, 2016 updated by: Transonic Systems Inc.

Measurement of Recirculation, Oxygenator Blood Volume and Cardiac Output in ECMO Using a Modified Transonic Systems (tm) HD02 Monitoring System

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan, Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Measurement of cardiac output in venoarterial extracorporeal membrane oxygenation patients, recirculation in venovenous extracorporeal membrane oxygenation patients and oxygenator blood volume in venoarterial and venovenous extracorporeal membrane oxygenation patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac output, recirculation or oxygenator blood volume measurements made in patients receiving extracorporeal membrane oxygenation.
Time Frame: Duration of extracorporeal membrane oxygenation
Duration of extracorporeal membrane oxygenation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transonic Systems Inc.

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Nikolai M Krivitski, PhD, DSc, Transonic Systems Inc.
  • Principal Investigator: Jonathan Haft, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TSI-G-HCE101-2A-H
  • 1R43HL082022-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Output

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe