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

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ClinicalTrials.gov Identifier: NCT01299441
Recruitment Status : Terminated (unable to complete statistical analysis)
First Posted : February 18, 2011
Last Update Posted : March 24, 2017
ConMed Corporation
Information provided by (Responsible Party):
Timothy S. Shine, M.D., Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment
Liver Transplantation Device: ECOM ETT

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Noninvasive ECOM Monitoring of Hemodynamic Parameters During Liver Transplantation
Actual Study Start Date : February 2011
Primary Completion Date : December 2013
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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)

Primary Outcome Measures :
  1. 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.

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Timothy S. Shine, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01299441     History of Changes
Other Study ID Numbers: 10-007600
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017