跳至主要内容
临床试验/NCT01818895
NCT01818895已完成不适用

Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit: Impact on Relatives, Care Givers and the Dying Process - A Prospective, Multicenter, Observational Study

Centre Hospitalier Departemental Vendee44 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
458
试验地点
44
主要终点
Post traumatic Stress Disorder

研究概览

简要总结

The purpose of the study is to assess the dying process in critically ill patients with decision to withdraw invasive mechanical ventilation in anticipation of death and to compare effects of extubation and those of terminal weaning of mechanical ventilation on relatives and care givers. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • End of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay

排除标准

  • Age under 18 years
  • Non invasive mechanical ventilation
  • Brain death
  • Death before withdrawal of mechanical ventilation
  • No French-speaking relative
  • Refusal of relative to participate the study

结局指标

主要结局

Post traumatic Stress Disorder

时间窗: three month after patient's death

Post traumatic Stress Disorder as assessed by the Impact of event Scale-revised(IES-R)

次要结局

  • Complicated grief(6 and 12 months after patient's death)
  • Burn out syndrome of the physician(within day 1 after patient's death)
  • Post traumatic Stress Disorder(12 months after patient's death)
  • Relative's satisfaction(3 months after patient's death)
  • Physician's satisfaction(within day 1 after patient's death)
  • Burn out syndrome of the nurse(within day 1 after patient's death)
  • Anxiety and depression(3, 6 and 12 months after patient's death)
  • Nurse's satisfaction(within day 1 after patient's death)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (44)

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