Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00920062
First received: June 11, 2009
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

This study is to test the usefulness of ultrasound dilution recirculation measurements in patients receiving venovenous extracorporeal membrane oxygenation as therapy. The ultrasound dilution measurements determine the efficiency of support provided by venovenous extracorporeal membrane oxygenation. At the present time there are no other devices available to make recirculation measurements.


Condition Intervention
Venovenous Extracorporeal Membrane Oxygenation
Recirculation
Device: Ultrasound dilution recirculation measurements

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrasound Dilution Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation

Resource links provided by NLM:


Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation. [ Time Frame: Duration of venovenous extracorporeal membrane oxygenation ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound Dilution Recirculation
Patients in this arm of the study are receiving venovenous extracorporeal membrane oxygenation therapy. Recirculation measurements will be made during the course of therapy using an ultrasound dilution technique.
Device: Ultrasound dilution recirculation measurements
Ultrasound dilution recirculation measurements will be made in patients receiving venovenous extracorporeal membrane oxygenation as treatment.

Detailed Description:

At the present time there are no devices available to measure recirculation in patients on venovenous 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 patient and their extracorporeal circuit.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 0 and 21 years of age
  • Patients receiving venovenous extracorporeal membrane oxygenation as treatment.

Exclusion Criteria:

  • Patients over 21 years of age
  • Patients not receiving venovenous extracorporeal membrane oxygenation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00920062

Locations
United States, New York
Crouse Hospital
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Transonic Systems Inc.
Investigators
Principal Investigator: Nikolai M Krivitski, PhD, DSc Transonic Systems Inc.
Principal Investigator: Bonnie L Marr, MD Crouse Hospital
  More Information

Publications:
Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00920062     History of Changes
Other Study ID Numbers: TSI-C-HCE101-3A-H, 2R44HL082022-02
Study First Received: June 11, 2009
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Transonic Systems Inc.:
recirculation
ultrasound dilution
venovenous extracorporeal membrane oxygenation

ClinicalTrials.gov processed this record on September 18, 2014