Evaluation of the ECOM™ Monitor for Continuous and Non-invasive Measure of the Cardiac Output in Cardiac Surgery Patients (EVALECOM2)

October 13, 2016 updated by: Hopital Foch
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Plessis Robinson, France, 92350
        • Centre chirurgical Marie-Lannelongue
      • Paris, France, 75014
        • Institut Mutualiste Montsouris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Surgery
Device: ECOM™.
Device: Trans-esophageal echography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac output
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012/11
  • 2012-A00398-35 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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