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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: May 25, 2016
Last verified: May 2016
  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
Recirculation
Oxygenator Blood Volume
Cardiac Output
Venoarterial Extracorporeal Membrane Oxygenation
Venovenous Extracorporeal Membrane Oxygenation

Study Type: Observational
Study Design: Time Perspective: Prospective
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)
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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: May 25, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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 September 26, 2016