Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO)
This study is enrolling participants by invitation only.
Sponsor:
Transonic Systems Inc.
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 11, 2009 | ||||||||
| Last Updated Date | June 4, 2012 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation. [ Time Frame: Duration of venovenous extracorporeal membrane oxygenation ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00920062 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO) | ||||||||
| Official Title ICMJE | Ultrasound Dilution Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Ultrasound dilution recirculation measurements
Ultrasound dilution recirculation measurements will be made in patients receiving venovenous extracorporeal membrane oxygenation as treatment. |
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| Study Arm (s) | 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 |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 15 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 21 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00920062 | ||||||||
| Other Study ID Numbers ICMJE | TSI-C-HCE101-3A-H, 2R44HL082022-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Transonic Systems Inc. | ||||||||
| Study Sponsor ICMJE | Transonic Systems Inc. | ||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Transonic Systems Inc. | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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