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临床试验/NCT01930643
NCT01930643终止不适用

Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure

Mackay Memorial Hospital1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
1
主要终点
Ventilator-free Days

研究概览

简要总结

Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease.

Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days.

Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.

详细描述

Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3).

EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).

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
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient required mechanical ventilation more than 14 days
  • No ability for active endurance exercise because of poor consciousness or limb weakness.

排除标准

  • Pregnant women
  • Limb wound/infection interfered with electric pad application
  • Recent acute myocardial infarction or life-threatening arrhythmia
  • Uncontrolled epilepsy
  • Dying patients without attempt of ventilator weaning
  • Absence of respiratory drive

研究组 & 干预措施

Electric muscle stimulation(EMS)

Experimental

EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.

干预措施: EMS (Device)

Control

No Intervention

Patients with routine passive rehabilitation program.

结局指标

主要结局

Ventilator-free Days

时间窗: 28 days

the cumulative ventilator-free days after intervention, in following 28 days.

次要结局

  • Grip Power(7 days after intervention)

研究者

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

Kuang-Hua Cheng, MD

Visiting staff

Mackay Memorial Hospital

研究点 (1)

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