NCT02932371

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 11, 2016

Last Update Submit

October 13, 2016

Conditions

Cardiac Surgery

Keywords

Cardiac output

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    4 hours

Study Arms (1)

Cardiac Surgery

EXPERIMENTAL
Device: ECOM™.Device: Trans-esophageal echography

Interventions

ECOM™.DEVICE
Cardiac Surgery
Trans-esophageal echographyDEVICE
Cardiac Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over18 years
  • Needed cardiac surgery,
  • Needed a monitoring by transesophageal ultrasound ,
  • Benefiting from a social security scheme
  • Having given their written consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Chirurgical Marie-Lannelongue

Le Plessis-Robinson, 92350, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 13, 2016

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

July 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)