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

This study has been terminated.
(Study site collaborators withdrew from participating due to time constraints.)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00920569
First received: June 11, 2009
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Recirculation
Oxygenator Blood Volume
Cardiac Output
Venoarterial Extracorporeal Membrane Oxygenation
Venovenous Extracorporeal Membrane Oxygenation
 Device: Ultrasound dilution measurements

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measurement of Recirculation, Oxygenator Blood Volume and Cardiac Output in ECMO Using a Modified Transonic Systems (tm) HD02 Monitoring System

Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • Cardiac output, recirculation or oxygenator blood volume measurements made in patients receiving extracorporeal membrane oxygenation. [ Time Frame: Duration of extracorporeal membrane oxygenation ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound dilution
Patients in this arm of the study are receiving extracorporeal membrane oxygenation. Depending on the specific type of extracorporeal membrane oxygenation therapy, venoarterial or venovenous, patients will have cardiac output, recirculation and/or oxygenator blood volume measurements performed using an ultrasound dilution technique.
 Device: Ultrasound dilution measurements
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920569

Locations
United States, Michigan
University of Michigan, Medical School
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jonathan Haft, MD University of Michigan
Principal Investigator: Nikolai M Krivitski, PhD, DSc Transonic Systems Inc.
  More Information

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00920569     History of Changes
Other Study ID Numbers: TSI-G-HCE101-2A-H, 1R43HL082022-01
Study First Received: June 11, 2009
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Transonic Systems Inc.:
cardiac output
recirculation
oxygenator blood volume
venoarterial extracorporeal membrane oxygenation
venovenous extracorporeal membrane oxygenation

ClinicalTrials.gov processed this record on June 17, 2013