Neuromuscular Electrical Stimulation in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Muscle thickness
研究概览
简要总结
Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle strength if the patients are awake and cooperative (using the medical research council scale and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the investigators hypothesize that electrical stimulation will preserve muscle mass with respect to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that electrical stimulation can reduce muscle strength loss and leads to a better protein balance and thicker muscle fibers in the stimulated quadriceps.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult ICU patients with a predicted prolonged ICU stay
排除标准
- •Preexisting neuromuscular disease, polyneuropathy or myopathy (e.g. Guillain-Barré, myasthenia gravis, Amyotrophic Lateral Sclerosis, paraplegia, multiple sclerosis, ...)
- •Receiving neuromuscular blocking agents
- •Musculoskeletal conditions of the pelvis and/or lower limb (e.g. fractures, skin disease )
- •Focal neurological conditions of the pelvis and/or lower limb
- •Skin disease (e.g. burns)
- •Presence of a pace-maker or defibrillator
- •Hemodynamic or Respiratory Instability, active cardiac ischemia
- •High fever (>39°)
- •Pregnancy
- •Brain death
- •Intracranial pressure >20 mmHg
- •An anticipated fatal outcome
- •Psychiatric disorders or severe agitation
- •Re-admission to the ICU
研究组 & 干预措施
electrical stimulation
Compex 3 professional NMES for 60' per day
干预措施: electrical stimulation (Other)
control
结局指标
主要结局
Muscle thickness
时间窗: post intervention period
Ultrasound measure in cm
次要结局
- Muscle strength (MRC & HHD)(post intervention period)
- Muscle fiber thickness(post intervention period)
- Protein balance(post intervention)