Liver TransplantationNCT01299441
Endotracheal Cardiac Output Monitor (ECOM) for Patients Undergoing Liver Transplantation
An observational study of Liver Transplantation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the endotracheal cardiac output monitor (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory changes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- ECOM ETT
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Oct 2016
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing liver transplantation
Who may be able to join
- Patients undergoing liver transplantation surgery
Who cannot join
- Patients who are anticipated to remain intubated postoperatively for greater than 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive ECOM Monitoring of Hemodynamic Parameters During Liver Transplantation
The purpose of this study is to determine whether the endotracheal cardiac output monitor (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory changes.
- Conditions
- Liver Transplantation
- Being tested
- ECOM ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECOM ETTDevice
Intubation with ECOM endotracheal tube (ETT)
| Study group | Role | What they receive |
|---|---|---|
| OLT patients intubated with ECOM ETT | Patients undergoing liver transplantation and intubated with ECOM endotracheal tube (ETT). Receives: Device: ECOM ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
endotracheal cardiac output monitor (ECOM), a non-invasive cardiac output monitor, is accurate and predictive
Pulmonary artery catheters are a standard of care for intraoperative hemodynamic assessment during liver transplantation. We propose to compare hemodynamic parameters obtained from PA catheters and ECOM. Use the endotracheal cardiac output monitor (ECOM) to evaluate multiple hemodynamic parameters (invasive blood pressure from the indwelling arterial catheter, noninvasive cardiac output via ECOM), and compare these to the parameters obtained from PA catheter.
Measured: Less than 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionOct 2016
Why it stopped: unable to complete statistical analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- CONMED Corporation
- Responsible party
- Principal investigator, Timothy S. Shine, M.D., Mayo Clinic
- Investigators
- Timothy Shine, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299441
- Sponsor's protocol ID
- 10-007600
- Status last verified
- Mar 2017
- First submitted
- 9 Feb 2011
- Last updated
- 24 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive ECOM Monitoring of Hemodynamic Parameters During Liver Transplantation
- ClinicalTrials.gov ID
- NCT01299441
- Acronym / sponsor ID
- 10-007600
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: unable to complete statistical analysis
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- CONMED Corporation
- Study start
- Feb 2011 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Feb 2011 (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.
The purpose of this study is to determine whether the endotracheal cardiac output monitor (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory changes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLT patients intubated with ECOM ETT | – | Device: ECOM ETTPatients undergoing liver transplantation and intubated with ECOM endotracheal tube (ETT). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver transplantation
Key inclusion criteria (1 listed)
- Patients undergoing liver transplantation surgery
Key exclusion criteria (1 listed)
- Patients who are anticipated to remain intubated postoperatively for greater than 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECOM ETTIntubation with ECOM endotracheal tube (ETT) | Device | OLT patients intubated with ECOM ETT |
Primary outcome
endotracheal cardiac output monitor (ECOM), a non-invasive cardiac output monitor, is accurate and predictive
Time frame: Less than 24 hours
Pulmonary artery catheters are a standard of care for intraoperative hemodynamic assessment during liver transplantation. We propose to compare hemodynamic parameters obtained from PA catheters and ECOM. Use the endotracheal cardiac output monitor (ECOM) to evaluate multiple hemodynamic parameters (invasive blood pressure from the indwelling arterial catheter, noninvasive cardiac output via ECOM), and compare these to the parameters obtained from PA catheter.
Results and safety
The study was stopped early (reason given: unable to complete statistical analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
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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.
Timothy Shine, MD principal investigator
Mayo Clinic
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 Liver Transplantation, run by Mayo Clinic 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 24 Mar 2017. 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: unable to complete statistical analysis). 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?
endotracheal cardiac output monitor (ECOM), a non-invasive cardiac output monitor, is accurate and predictive (time frame: Less than 24 hours). 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 24 Mar 2017.