Evaluation of the ECOM™ Monitor for Continuous and Non-invasive Measure of the Cardiac Output in Cardiac Surgery Patients

Hopital Foch2 sites in 1 country5 target enrollmentJanuary 2013

ConditionsCardiac Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiac Surgery
Sponsor: Hopital Foch
Enrollment: 5
Locations: 2
Primary Endpoint: Cardiac output
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to estimate the reliability of the determination of the cardiac output measured by the ECOM™ device. This study will be performed with the latest version of the software which should give better results than those published previously. Two techniques of measure of the cardiac output will be compared: the reference measure by trans-esophageal echography and the bioimpedance used by the ECOM™. monitor.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients over18 years
•Needed cardiac surgery,
•Needed a monitoring by transesophageal ultrasound ,
•Benefiting from a social security scheme
•Having given their written consent.

Exclusion Criteria

•Pregnant or breast-feeding women,
•Allergy to polyvinylchloride (PVC),
•The patients for whom a difficulty of ventilation with a mask or intubation is envisaged,
•Contraindication to transesophageal ultrasound, a steady cardiac arrhythmia, a flight or an aortic shrinkage.