RecirculationNCT00920569
Recirculation, Oxygenator Blood Volume and Cardiac Output Measurements During Extracorporeal Membrane Oxygenation
An observational study of Recirculation and Oxygenator Blood Volume, run by Transonic Systems Inc. at 1 site in United States.
Trial summary
This study is to test the usefulness of ultrasound dilution measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recirculation, Oxygenator Blood Volume, Cardiac Output
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Aug 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Measurement of cardiac output in venoarterial extracorporeal membrane oxygenation patients, recirculation in venovenous extracorporeal membrane oxygenation patients and oxygenator blood volume in venoarterial and venovenous extracorporeal membrane oxygenation patients.
Who may be able to join
- Neonatal, pediatric or adult patients receiving venoarterial or venovenous extracorporeal membrane oxygenation.
Who cannot join
- Patients not receiving venoarterial or venovenous extracorporeal membrane oxygenation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Medical School
Ann Arbor, Michigan, 48109
About this study
Official title: Measurement of Recirculation, Oxygenator Blood Volume and Cardiac Output in ECMO Using a Modified Transonic Systems (tm) HD02 Monitoring System
This study is to test the usefulness of ultrasound dilution measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). At the present time there are no devices available to perform these functions.
Read the detailed description
At the present time there are no devices available to measure recirculation, oxygenator blood volume and cardiac output in patients on 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 extracorporeal circuit.
- Conditions
- Recirculation, Oxygenator Blood Volume, Cardiac Output, Venoarterial Extracorporeal Membrane Oxygenation, Venovenous Extracorporeal Membrane Oxygenation
- Keywords
- cardiac output, recirculation, oxygenator blood volume, venoarterial extracorporeal membrane oxygenation, venovenous extracorporeal membrane oxygenation
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output, recirculation or oxygenator blood volume measurements made in patients receiving extracorporeal membrane oxygenation.
Measured: Duration of 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 startMay 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Study site collaborators withdrew from participating due to time constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecirculationStudies 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
- 8 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
- Jonathan Haft, MD, Principal investigator, University of MichiganNikolai M Krivitski, PhD, DSc, Principal investigator, Transonic Systems Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920569
- Sponsor's protocol ID
- TSI-G-HCE101-2A-H
- Other IDs
- 1R43HL082022-01
- Status last verified
- May 2016
- First submitted
- 11 Jun 2009
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Measurement of Recirculation, Oxygenator Blood Volume and Cardiac Output in ECMO Using a Modified Transonic Systems (tm) HD02 Monitoring System
- ClinicalTrials.gov ID
- NCT00920569
- Acronym / sponsor ID
- TSI-G-HCE101-2A-H
- Conditions
- Recirculation, Oxygenator Blood Volume, Cardiac Output, Venoarterial Extracorporeal Membrane Oxygenation, Venovenous Extracorporeal Membrane Oxygenation
- Keywords
- cardiac output, recirculation, oxygenator blood volume, venoarterial extracorporeal membrane oxygenation, venovenous extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study site collaborators withdrew from participating due to time constraints.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (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 measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). At the present time there are no devices available to perform these functions.
Detailed description
At the present time there are no devices available to measure recirculation, oxygenator blood volume and cardiac output in patients on 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 extracorporeal circuit.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Measurement of cardiac output in venoarterial extracorporeal membrane oxygenation patients, recirculation in venovenous extracorporeal membrane oxygenation patients and oxygenator blood volume in venoarterial and venovenous extracorporeal membrane oxygenation patients.
Key inclusion criteria (1 listed)
- Neonatal, pediatric or adult patients receiving venoarterial or venovenous extracorporeal membrane oxygenation.
Key exclusion criteria (1 listed)
- Patients not receiving venoarterial or 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
Cardiac output, recirculation or oxygenator blood volume measurements made in patients receiving extracorporeal membrane oxygenation.
Time frame: Duration of extracorporeal membrane oxygenation
Results and safety
The study was stopped early (reason given: Study site collaborators withdrew from participating due to time constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Individual participant dataSharing planned: No
Related trials for Recirculation
RecruitingObservational study
Reduction of Blood Recirculation in Veno-Venous ECMO
Extracorporeal Membrane Oxygenation, Acute Respiratory Distress Syndrome
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.
Jonathan Haft, MD principal investigator
University of Michigan
Nikolai M Krivitski, PhD, DSc principal investigator
Transonic Systems Inc.
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 Recirculation and Oxygenator Blood Volume, 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 1 inclusion and 1 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: stopped early, 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 was stopped early (reason given: Study site collaborators withdrew from participating due to time constraints.). Results are not available in the source record.
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?
Cardiac output, recirculation or oxygenator blood volume measurements made in patients receiving extracorporeal membrane oxygenation. (time frame: Duration of extracorporeal membrane oxygenation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.