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临床试验/NCT01535716
NCT01535716已完成4 期

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?

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
2
主要终点
length of hospital stay

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

length of hospital stay

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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