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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

June 11, 2009
June 4, 2012
June 2007
June 2012   (final data collection date for primary outcome measure)
Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation. [ Time Frame: Duration of venovenous extracorporeal membrane oxygenation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00920062 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO)
Ultrasound Dilution Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Venovenous Extracorporeal Membrane Oxygenation
  • Recirculation
Device: Ultrasound dilution recirculation measurements
Ultrasound dilution recirculation measurements will be made in patients receiving venovenous extracorporeal membrane oxygenation as treatment.
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.
Intervention: Device: Ultrasound dilution recirculation measurements
Clements D, Primmer J, Ryman P, Marr B, Searles B, Darling E. Measurements of recirculation during neonatal veno-venous extracorporeal membrane oxygenation: clinical application of the ultrasound dilution technique. J Extra Corpor Technol. 2008 Sep;40(3):184-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
15
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00920062
TSI-C-HCE101-3A-H, 2R44HL082022-02
No
Transonic Systems Inc.
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Nikolai M Krivitski, PhD, DSc Transonic Systems Inc.
Principal Investigator: Bonnie L Marr, MD Crouse Hospital
Transonic Systems Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP