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TerminatedNCT01299441Updated Mar 24, 2017

Endotracheal Cardiac Output Monitor (ECOM) for Patients Undergoing Liver Transplantation

An observational study in Liver Transplantation, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by Mayo Clinic · Observational

Why this study was terminated
unable to complete statistical analysis
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Transplantation
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing liver transplantation

Inclusion criteria

  • Patients undergoing liver transplantation surgery

Exclusion criteria

Exclusion Criteria:

  • Patients who are anticipated to remain intubated postoperatively for greater than 24 hours.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (actual)

Groups and cohorts

  • OLT patients intubated with ECOM ETT

    Patients undergoing liver transplantation and intubated with ECOM endotracheal tube (ETT).

    Device: ECOM ETT

Interventions

  • DeviceECOM ETT

    Intubation with ECOM endotracheal tube (ETT)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Less than 24 hours

07

Study locations

1 site
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01299441
Lead sponsor
Mayo Clinic
Collaborators
CONMED Corporation
Responsible party
Timothy S. Shine, M.D. (PI, Mayo Clinic) — Principal investigator
First posted
Feb 18, 2011
Start date
Feb 2011
Primary completion
Dec 2013
Completion
Oct 2016
Last update
Mar 24, 2017

Study contacts

Timothy Shine, MD
principal investigator · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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