The Effects of Early Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in muscle thickness of pectoral and rectus abdominis muscles
研究概览
简要总结
Neuromuscular electrical stimulation in pectoral muscles (fibres of the pectoralis major muscle bilaterally) and rectus abdominis muscles (bilaterally) preserves / decreases the loss of muscle mass.
详细描述
Introduction
Neuromuscular electrical stimulation (NMES) has recently began to be used as an early treatment method for Intensive Care Unit (ICU) patients on invasive mechanical ventilation (IMV) to compensate for or reduce muscle mass losses and muscular atrophy.
Objective
To evaluate the effects of early mobilization with neuromuscular electrical stimulation in critical care patients on invasive mechanical ventilation.
Methods: Randomized clinical trial to be conducted in the ICU at the hospital de clínicas of Porto Alegre, RS, Brazil, with two groups, one intervention group (conventional physiotherapy and NMES) and one placebo group (conventional physiotherapy and placebo NMES). Patients on mechanical ventilation who meet the inclusion criteria will be recruited and the intervention will be administered using a 4-channel Ibramed® Neurodyn Functional Electrical Stimulation (FES) machine, every day for thirty minutes until extubation or death. Outcomes will be muscle thickness of pectoral and abdominal muscles and diaphragm excursion measured with ultrasound, before intervention, on the seventh day of intervention and soon after extubation. Additionally, blood lactate and heart rate variability will be assessed. Statistical analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) 20.0 and the significance level will be p<0.05.
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
- Double (Participant, Outcomes Assessor)
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
- •This will be a randomized clinical trial recruiting patients of both sexes aged ≥ 18 years, no more than 15 days after admission to the intensive care unit at the hospital de clínicas de Porto Alegre, after transfer from the emergency department or wards and put on invasive mechanical ventilation for at least 24 hours
排除标准
- •Exclusion criteria will include neuromuscular diseases causing motor deficits, such as strokes, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis and Guillain Barré syndrome. Patients will also be excluded in the event of extubation less than 48 hours after enrolment on the study; complications during the protocol, such as pneumothorax, reintubation or delayed weaning (3 failed spontaneous ventilation tests); body mass index (BMI) > 35 kg/m2; pacemaker use, history of epilepsy; or if a patient has undergone an operation involving abdominal or pectoral incisions.
结局指标
主要结局
Change in muscle thickness of pectoral and rectus abdominis muscles
时间窗: baseline and after seven days of protocol or 24 hours after extubation
The initial examination by ultrasound will be performed on the first day of the individual in the protocol and the final examination on the seventh day of the protocol
次要结局
- Change Thickness of Diaphragm(baseline and after seven days of protocol or 24 hours after extubation .)
- Change Excursion of the Diaphragm(baseline and after seven days of protocol or 24 hours after extubation .)
- blood lactate levels(first day of protocol)