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Completed

NCT Number: NCT01535716

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Caen

Caen, Calvados, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hemodynamic optimization strategy driven by the ECOM

Behavioral

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

standard management strategy

Behavioral

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

Primary outcomes

  1. length of hospital stay

    Time frame: 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 outcomes

  1. Number of major adverse cardiac events during stay in hospital

    Time frame: 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

  2. Length of stay in ICU

    Time frame: at the exit of ICU or at death, if during hospital stay.expected before 1 month

  3. In-hospital mortality

    Time frame: at the end of the study. up to 12 month

  4. Number of patients with Major adverse cardiac events during in-hospital stay.

    Time frame: at the end of the study. Up to 12 month

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • CONMED Corporation

Registry information

Official study title

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?

Acronym: ECOMIII

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2012
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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