Effects of a Goal-directed Hemodynamic Therapy Driven by ECOM on Morbidity and Mortality After Cardiac Surgery? (ECOMIII)

Does Goal-directed Hemodynamic Therapy Driven by Endotracheal Cardiac Output Monitoring System During Surgical Intervention Reduce Hospital Stay and Major Adverse Cardiac Events Following Cardiac Surgery?

Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic optimizations are more efficient when based on the dynamic parameters than when based on the statics ones, and the major dynamic criteria is the cardiac output. Unfortunately, transpulmonary thermodilution, the device considered as "The gold standard" to evaluate cardiac output is associated with many complications.Furthermore, devices commercialized in the past decade were not able to replace the transpulmonary thermodilution.

As all monitoring devices aren't reliable enough to be widely used in practice they are left aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on the analysis of several clinical parameters seems to guarantee good cares thanks to a favorable benefits/risks balance, it could be improved by new plug and play mini-invasive systems.

In the investigators opinion, the ECOM system seems able to provide a monitoring tool which responds to all the expectations of a modern hemodynamic monitoring device. It uses a well known technique, the bioimpedance. The investigators suppose this device should be more efficient than the one that has been used before. Indeed, as the system is build on the endotracheal tube, it comes closer to the aorta, where all the measures are made, and the recorded signal should be less affected by the passage through the surrounding tissues.

This randomized and controlled trial will study Patients scheduled for elective coronary surgery with cardiopulmonary bypass.

The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed hemodynamic therapy based on the ECOM cardiac output measure on mortality and major postoperative cardiac morbidity after coronary surgery, when compared with a standard management strategy.

Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard management strategy, applied to the control group, will be set and led by the attending anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke volume variation.

The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure will reduce mortality and morbidity after cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Coronary Surgery With Cardiopulmonary Bypass
• Intervention / Treatment: Behavioral: hemodynamic optimization strategy driven by the ECOM; Behavioral: standard management strategy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14000
      • University hospital of Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any man or woman
• Over 18 year-old
• After obtaining written informed consent
• Scheduled for elective coronary surgery with CPB

Exclusion Criteria:

• Emergency surgery (< 24h)
• Combined cardiac surgery
• Patients < 18 years-old and/or unable to give informed consent
• Patients who refuse to give informed consent
• Pregnancy
• PVC allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECOM group; 50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass	Behavioral: hemodynamic optimization strategy driven by the ECOM; goal directed hemodynamic therapy is based on the ECOM evaluation of stroke volume variation (SVV) & cardiac index (CI). goals: SVV < 11%; IC > 2,2 ml/min/m² During the anesthesia; Other Names: Endotracheal cardiac output monitoring
Active Comparator: standard management group; 50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass	Behavioral: standard management strategy; goal directed hemodynamic therapy will be set and performed by the attending anesthetist, based on the analysis of further clinical parameters: Standard monitoring : heart rate, saturation index; Diuresis > 0,5ml/kg/h; Blood pressure , PAM > 65 mmHg; Pulse pressure variation; CVP 8 to 12 cmH20; Visual aspect of the heart; Overload signs During the anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
length of hospital stay	Data collected at the exit of hospital or at death, if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days. expected before 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of major adverse cardiac events during stay in hospital	Data collected at the exit of ICU, at the exit of hospital or at death if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days.Up to 1 month
Length of stay in ICU	at the exit of ICU or at death, if during hospital stay.expected before 1 month
In-hospital mortality	at the end of the study. up to 12 month
Number of patients with Major adverse cardiac events during in-hospital stay.	at the end of the study. Up to 12 month

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: CONMED Corporation
• Investigators: Study Director: Jean-Luc Fellahi, EA3212: groupe coeur et ischémie

Publications and helpful links

General Publications

• Fellahi JL, Brossier D, Dechanet F, Fischer MO, Saplacan V, Gerard JL, Hanouz JL. Early goal-directed therapy based on endotracheal bioimpedance cardiography: a prospective, randomized controlled study in coronary surgery. J Clin Monit Comput. 2015 Jun;29(3):351-8. doi: 10.1007/s10877-014-9611-5. Epub 2014 Nov 9.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (Estimated): February 20, 2012

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 2011-A01210-41