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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00920062
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 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
Venovenous Extracorporeal Membrane Oxygenation
Recirculation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ultrasound Dilution Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation

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 ]

Enrollment: 16
Study Start Date: June 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonatal and/or pediatric patients receiving venovenous extracorporeal membrane oxygenation as treatment.
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
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: NCT00920062

Locations
United States, New York
Crouse Hospital
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
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: May 25, 2016
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 July 21, 2016