MedPath

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

Not Applicable
Terminated
Conditions
Cardiac Surgery
Interventions
Device: ECOM™.
Device: Trans-esophageal echography
Registration Number
NCT02932371
Lead Sponsor
Hopital Foch
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
5
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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Cardiac SurgeryTrans-esophageal echography-
Cardiac SurgeryECOM™.-
Primary Outcome Measures
NameTimeMethod
Cardiac output4 hours
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Centre Chirurgical Marie-Lannelongue

🇫🇷

Le Plessis Robinson, France

Institut Mutualiste Montsouris

🇫🇷

Paris, France

© Copyright 2025. All Rights Reserved by MedPath