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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
ConMed Corporation
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01299441
First received: February 9, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Timothy Shine, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01299441     History of Changes
Other Study ID Numbers: 10-007600
Study First Received: February 9, 2011
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013