Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO)
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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 |
- 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 |
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| United States, New York | |
| Crouse Hospital | |
| Syracuse, New York, United States, 13210 | |
| 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 May 22, 2013