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临床试验/NCT01047852
NCT01047852已完成不适用

Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders

University Hospital, Bordeaux10 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
144
试验地点
10
主要终点
Incidence of respiratory failure after extubation

研究概览

简要总结

The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.

详细描述

Reintubation, which occurs in 6 to 23% within 48 to 72 hours after planned extubation, is a relevant consequence of respiratory failure after extubation. Patients with chronic respiratory disorders and invasively mechanically ventilated in intensive care unit, often exhibit hypercapnia, during breathing trial prior extubation. This is associated to increased incidence of extubation failure and mortality. Although the need for reintubation may be a marker of increased severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. NIV does not seem to be beneficial in avoiding reintubation when these patients have developed respiratory failure. However, a recent randomised study demonstrated that the early use of NIV averted respiratory failure after extubation in patients at increased risk. The patients were considered at risk if they had at least one of the following criteria: age > 65 years, cardiac failure, increased severity assessed by an Acute Physiologic and Chronic Health Evaluation score > 12. But, the beneficial effects of NIV on survival appear to be restricted to patients with chronic respiratory disorders and hypercapnia during the spontaneous breathing trial. So the beneficial effects of NIV should be confirmed in a trial in this specific population. We planned to conduct a study evaluating the efficacy of NIV in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to NIV group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU and hospital mortality, 28-day survival, the complications associated to mechanical ventilation, ICU and hospital length of stay.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Patients intubated for 48 hours or more
  • Patients with Chronic respiratory disorders
  • And/or hypercapnic respiratory failure during successful spontaneous breathing trial

排除标准

  • Face or cranial trauma or surgery
  • Home noninvasive ventilation
  • Recent gastric or oesophageal surgery
  • Tracheostomy or other upper airway disorders
  • Upper gastrointestinal bleeding
  • Excess respiratory secretions
  • Lack of collaboration
  • Do not resuscitate order or any decision to limit therapeutic effort in the ICU.

结局指标

主要结局

Incidence of respiratory failure after extubation

时间窗: 2 days

次要结局

  • Incidence of reintubation(2 months)
  • Length of stay in Intensive Care Unit(2 months)
  • Hospital mortality(2 months)
  • Survival(90th day)
  • Incidence of complications associated to mechanical ventilation(2 months)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (10)

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