- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00920062
Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO)
May 25, 2016 updated by: Transonic Systems Inc.
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Syracuse, New York, United States, 13210
- Crouse Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neonatal and/or pediatric patients receiving venovenous extracorporeal membrane oxygenation as treatment.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation.
Time Frame: Duration of venovenous extracorporeal membrane oxygenation
|
Duration of venovenous extracorporeal membrane oxygenation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nikolai M Krivitski, PhD, DSc, Transonic Systems Inc.
- Principal Investigator: Bonnie L Marr, MD, Crouse Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
June 11, 2009
First Submitted That Met QC Criteria
June 12, 2009
First Posted (Estimate)
June 15, 2009
Study Record Updates
Last Update Posted (Estimate)
May 27, 2016
Last Update Submitted That Met QC Criteria
May 25, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- TSI-C-HCE101-3A-H
- 2R44HL082022-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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