Early Mobilization With a Cycle Ergometer for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit (MoVe-ICU Study): Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- change in cross-sectional quadriceps thickness
研究概览
简要总结
A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate the effects on critical patients on invasive mechanical ventilation of early mobilization with a cycle ergometer.
详细描述
A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate the effects on critical patients on invasive mechanical ventilation of early mobilization with a cycle ergometer. Patients (age > 18 years) will be recruited for this study from among those admitted to the intensive care department at the Hospital de Clínicas de Porto Alegre. Eligible patients will have been on invasive mechanical ventilation for at least 24 to 48 hours, will have spent maximum of 1 week in hospital and will not exhibit any characteristics restricting lower extremity mobility. These subjects will be randomized to receive either conventional physiotherapy or conventional physiotherapy with an additional cycle ergometer intervention. The intervention will be administered passively for 20 minutes, at 20 revolutions per minute, once per day, throughout the time the patients remain on invasive mechanical ventilation.
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
- Single (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
- •patients of both sexes aged >= 18 years will be recruited from among those admitted to the Hospital de Clínicas de Porto Alegre intensive care unit and put on invasive mechanical ventilation invasive mechanical ventilation for at least 24 to 48 hours after transfer from the emergency department or wards, no more than 1 week after admission
排除标准
- •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 the following: extubation less than 48 hours after enrollment on the study
- •haemodynamic instability (noradrenaline > 0.5 mc/kg/min for arterial blood pressure > 60 mmHg)
- •complications during the protocol such as pneumothorax, deep vein thrombosis or pulmonary embolism
- •Shilley catheter in the femoral vein
- •reintubation
- •delayed weaning (3 failed spontaneous ventilation tests)
- •body mass index > 35 kg/m2
- •emergence of eschar in the calcaneus area during the protocol.
结局指标
主要结局
change in cross-sectional quadriceps thickness
时间窗: baseline and after seven days of protocol
ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness
次要结局
- change in diaphragm excursion(baseline and after seven days of protocol)
- change in length of fascicle(baseline and after seven days of protocol)
- change in diaphragm thickness(baseline and after seven days of protocol)
- change in pennation angle of fascicles(baseline and after seven days of protocol)
- change in thickness of vastus lateralis muscle(baseline and after seven days of protocol)