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

Venovenous Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

Ultrasound Dilution Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920062
• Other study ID #: TSI-C-HCE101-3A-H
• Secondary ID: 2R44HL082022-02
• Status: Completed
• Phase: N/A
• First received: June 11, 2009
• Last updated: May 25, 2016
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: May 2016
• Source: Transonic Systems Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Recirculation
• Venovenous Extracorporeal Membrane Oxygenation

Locations

Country	Name	City	State
United States	Crouse Hospital	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Transonic Systems Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation.		Duration of venovenous extracorporeal membrane oxygenation	No