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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Cardiac Surgery

Group Type EXPERIMENTAL

ECOM™.

Intervention Type DEVICE

Trans-esophageal echography

Intervention Type DEVICE

Interventions

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ECOM™.

Intervention Type DEVICE

Trans-esophageal echography

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No