NCT04750265已完成不适用
Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Level of mobilization
研究概览
简要总结
Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Invasive mechanically ventilated and expected to be ventilated for another 24 hours
- •Cardiovascular stability, allowing mobilization
- •Respiratory stability, allowing mobilization
排除标准
- •Bed-bound before ICU admission
- •Bed-rest order or contraindication of weight load of the lower extremity or spine
- •Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis
- •Fresh SAB, ICB or elevated ICP
- •Status epilepticus
- •Acute intoxication
- •Shock with catecholamine doses >0.3μg/kg/min or acute bleeding including organ ruptures
- •Multiorgan failure with lactate > 4 mmol/l
- •Body height outside the range 150-195 cm
- •Body weight outside the range 45-135 kg
- •Pacemakers or other electrical stimulators
- •Implanted medical pumps
- •Pregnancy
- •Life expectancy below 7 days or acute palliative care situation
- •Death inevitable or maximum therapy is not carried out by the treating physicians or due to patient's request
- •Unable to understand the official language
结局指标
主要结局
Level of mobilization
时间窗: 5 days
Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10)
次要结局
- Days of sedation(during ICU stay (normally up to 30 days))
- Mortality(at 180 days after study start)
- Functional status(at 180 days after study start)
- Initiation of first Mobilization(5 days)
- Number of Health care provider(5 days)
- Health care provider assessment(5 days)
- Safety events(5 days after study start)
- Frequency of Mobilization(5 days)
- Mobilization duration(5 days)
- Muscle wasting(5 days)
- Depth of sedation(5 days)
- Days of mechanical ventilation(during ICU stay (normally up to 30 days))
- Days of Intubation(during ICU stay (normally up to 30 days))
- Days of Delirium(during ICU stay (normally up to 30 days))
- MRC Score(One time point before ICU Discharge)
- Length of stay(Hospital stay (approx. 30 days))
- Global function(at 180 days after study start)
- DRG workplace data(Hospital stay (approx. 30 days))
研究者
Stefan J Schaller
Deputy Clinical Director
Charite University, Berlin, Germany
研究点 (2)
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