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临床试验/NCT02706587
NCT02706587Unknown3 期

Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness

Institut Mutualiste Montsouris2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
3 期
入组人数
102
试验地点
2
主要终点
Medical resuscitation council (MRC) score

研究概览

简要总结

The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.

详细描述

Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • All patient
  • Aged of 18 or more
  • With an intended ICU stay of at least 72 hours
  • Mechanically ventilated

排除标准

  • Age less than 18 years
  • Pregnant women
  • Preexisting neuromuscular disease
  • Patient bearing a pace maker or an implantable defibrillator.
  • Poly traumatism and/or leg fracture.
  • End stage disease

结局指标

主要结局

Medical resuscitation council (MRC) score

时间窗: up to 25 months. From date of randomization to the date of ICU discharge

次要结局

  • Total duration of mechanical ventilation (days)(up to 25 months. From date of randomization to the date of ICU discharge)
  • Length of ICU stay and hospital stay.(up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge)
  • Type of hospital discharge(up to 25 months. From date of randomization to the date of hospital discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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