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临床试验/NCT02033057
NCT02033057Unknown4 期

Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.

Hospital Universitario La Fe2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
4 期
入组人数
40
试验地点
2
主要终点
muscular weakness

研究概览

简要总结

Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. The objective of this project is to analyze the effect of muscle electrostimulation (ESM) on muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a single center, prospective, randomized trial to be held in the ICU of " Universitarian hospital La Fe" in collaboration with the service of Neurophysiology of the hospital. All patients undergoing sedation and mechanical ventilation (with an expected duration longer than 48h) and without any of the exclusion criteria detailed in the Methodology section will be included in the study. The intervention will consist of a muscular electrostimulation with the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5 per side) following established protocols, at least 5 days a week. We will evaluate muscle strength by Medical Research Council scale, functional capacity by Barthel scale and Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic, echographic and histologic parameters will be measured. The process of extubation will be performed following an established protocol, the duration will be collected as the same manner as ICU.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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 older than 18 years.
  • Sedated and mechanically ventilated critically ill patients, more than 48 hours.

排除标准

  • Body mass index > 45 or < 20 kg/m
  • Pregnant.
  • Epilepsia.
  • Use muscular blocks.

结局指标

主要结局

muscular weakness

时间窗: at the time of weaning, 30 days after extubation and one year after extubation.

We measure the muscular weakness, with the medical research council scale.

次要结局

  • time of weaning(everyday)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paula Ramirez

doctor

Hospital Universitario La Fe

研究点 (2)

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