Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness
试验速览
- 阶段
- 3 期
- 入组人数
- 102
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Neuromuscular electrical stimulation
NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week.
干预措施: Neuromuscular electrical stimulation (Device)
Sham Control
No electrostimulation
干预措施: Sham control (Device)
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)