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

This study has been terminated.
(unable to complete statistical analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01299441
First Posted: February 18, 2011
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ConMed Corporation
Information provided by (Responsible Party):
Timothy S. Shine, M.D., Mayo Clinic
  Purpose
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)

  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Patients undergoing liver transplantation surgery

Exclusion Criteria:

  • Patients who are anticipated to remain intubated postoperatively for greater than 24 hours.
  Contacts and Locations
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


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

Responsible Party: Timothy S. Shine, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01299441     History of Changes
Other Study ID Numbers: 10-007600
First Submitted: February 9, 2011
First Posted: February 18, 2011
Last Update Posted: March 24, 2017
Last Verified: March 2017