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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02932371

Acronym

EVALECOM2

Enrollment

Registered

2016-10-13

Start date

2013-01-31

Completion date

2016-07-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

Cardiac output

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.

Interventions

DEVICEECOM™.

DEVICETrans-esophageal echography

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Cardiac output	4 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026