NCT01299441

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

February 9, 2011

Last Update Submit

March 22, 2017

Conditions

Liver Transplantation

Outcome Measures

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.

    Less than 24 hours

Study Arms (1)

OLT patients intubated with ECOM ETT

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

Device: ECOM ETT

Interventions

ECOM ETTDEVICE

Intubation with ECOM endotracheal tube (ETT)

OLT patients intubated with ECOM ETT

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing liver transplantation

You may qualify if:

  • Patients undergoing liver transplantation surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Study Officials

  • Timothy Shine, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 18, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

October 1, 2016

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

US(1)