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

This study has been terminated.
(unable to complete statistical analysis)
ConMed Corporation
Information provided by (Responsible Party):
Timothy S. Shine, M.D., Mayo Clinic Identifier:
First received: February 9, 2011
Last updated: March 22, 2017
Last verified: March 2017
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.

Condition Intervention
Liver Transplantation Device: ECOM ETT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Noninvasive ECOM Monitoring of Hemodynamic Parameters During Liver Transplantation

Resource links provided by NLM:

Further study details as provided by Timothy S. Shine, M.D., Mayo Clinic:

Primary Outcome Measures:
  • 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.

Enrollment: 40
Actual Study Start Date: February 2011
Study Completion Date: October 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
OLT patients intubated with ECOM ETT
Patients undergoing liver transplantation and intubated with ECOM endotracheal tube (ETT).
Device: ECOM ETT
Intubation with ECOM endotracheal tube (ETT)


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing liver transplantation

Inclusion Criteria:

  • Patients undergoing liver transplantation surgery

Exclusion Criteria:

  • Patients who are anticipated to remain intubated postoperatively for greater than 24 hours.
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Please refer to this study by its identifier: NCT01299441

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
ConMed Corporation
Principal Investigator: Timothy Shine, MD Mayo Clinic
  More Information

Responsible Party: Timothy S. Shine, M.D., PI, Mayo Clinic Identifier: NCT01299441     History of Changes
Other Study ID Numbers: 10-007600
Study First Received: February 9, 2011
Last Updated: March 22, 2017 processed this record on September 25, 2017