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

Study Overview
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Brief Summary
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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.

Official Title
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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?

Conditions
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Coronary Surgery With Cardiopulmonary Bypass

Intervention / Treatment
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* Behavioral: hemodynamic optimization strategy driven by the ECOM
* Behavioral: standard management strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECOM group<br>50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass | Behavioral: hemodynamic optimization strategy driven by the ECOM<br>* 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<br>* Other names: Endotracheal cardiac output monitoring;|
| Active Comparator: standard management group<br>50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass | Behavioral: standard management strategy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |