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

Hopital Foch

Status: Terminated

Conditions: Cardiac Surgery

Treatments: Device: Trans-esophageal echography; Device: ECOM™.

Study type: Interventional

Funder types: Other

Identifiers

NCT02932371

2012/11

2012-A00398-35 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

5 participants in 1 patient group

Cardiac Surgery

Experimental group

Treatment:

Device: Trans-esophageal echography

Device: ECOM™.