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

Cardiac Surgery Clinical Trial

— EVALECOM2  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02932371
• Other study ID #: 2012/11
• Secondary ID: 2012-A00398-35
• Status: Terminated
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 13, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 2016
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Device:
• ECOM™.

• Trans-esophageal echography

Locations

Country	Name	City	State
France	Centre Chirurgical Marie-Lannelongue	Le Plessis Robinson
France	Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output		4 hours	No