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

Liver Transplantation Clinical Trial

Official title:

Noninvasive ECOM Monitoring of Hemodynamic Parameters During Liver Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01299441
• Other study ID #: 10-007600
• Status: Terminated
• Phase: N/A
• First received: February 9, 2011
• Last updated: March 22, 2017
• Start date: February 2011
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients undergoing liver transplantation surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Device:
• ECOM ETT
Intubation with ECOM endotracheal tube (ETT)

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	ConMed Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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