Venovenous Extracorporeal Membrane OxygenationNCT00920062
Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO)
An observational study of Venovenous Extracorporeal Membrane Oxygenation and Recirculation, run by Transonic Systems Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Venovenous Extracorporeal Membrane Oxygenation, Recirculation
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Neonatal and/or pediatric patients receiving venovenous extracorporeal membrane oxygenation as treatment.
Who may be able to join
- Patients between 0 and 21 years of age
- Patients receiving venovenous extracorporeal membrane oxygenation as treatment.
Who cannot join
- Patients over 21 years of age
- Patients not receiving venovenous extracorporeal membrane oxygenation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- recirculation, ultrasound dilution, venovenous extracorporeal membrane oxygenation
What is being measured
The primary outcome is the main question the study is designed to answer.
Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation.
Measured: Duration of venovenous extracorporeal membrane oxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJun 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venovenous Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transonic Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nikolai M Krivitski, PhD, DSc, Principal investigator, Transonic Systems Inc.Bonnie L Marr, MD, Principal investigator, Crouse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920062
- Sponsor's protocol ID
- TSI-C-HCE101-3A-H
- Other IDs
- 2R44HL082022-02
- Status last verified
- May 2016
- First submitted
- 11 Jun 2009
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18853830
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Dilution Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT00920062
- Acronym / sponsor ID
- TSI-C-HCE101-3A-H
- Keywords
- recirculation, ultrasound dilution, venovenous extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Neonatal and/or pediatric patients receiving venovenous extracorporeal membrane oxygenation as treatment.
Key inclusion criteria (2 listed)
- Patients between 0 and 21 years of age
- Patients receiving venovenous extracorporeal membrane oxygenation as treatment.
Key exclusion criteria (2 listed)
- Patients over 21 years of age
- Patients not receiving venovenous extracorporeal membrane oxygenation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation.
Time frame: Duration of venovenous extracorporeal membrane oxygenation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Background: PubMed 18853830Clements 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolai M Krivitski, PhD, DSc principal investigator
Transonic Systems Inc.
Bonnie L Marr, MD principal investigator
Crouse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venovenous Extracorporeal Membrane Oxygenation and Recirculation, run by Transonic Systems Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation. (time frame: Duration of venovenous extracorporeal membrane oxygenation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00920062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.