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

Summary

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.

Conditions

• Coronary Surgery With Cardiopulmonary Bypass

Interventions

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

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

Sponsors & Collaborators

• CONMED Corporation

  collaborator INDUSTRY

• University Hospital, Caen

  lead OTHER

Principal Investigators

• Jean-Luc Fellahi · EA3212: groupe coeur et ischémie

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2013-02-28

Completion

2013-02-28

Countries

• France

Study Locations