NCT04423796已完成不适用
Robotic Assisted Early Mobilization in Ventilated ICU Patients: an Interventional Randomized, Controlled Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Feasibility of early mobilization
研究概览
简要总结
Feasibility trial investigating robotic assisted early mobilization vs. early mobilization 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
- Treatment
- 盲法
- None
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
- •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
- •ICU stay > 72h at the time of enrolment
- •Translated with www.DeepL.com/Translator (free version)
结局指标
主要结局
Feasibility of early mobilization
时间窗: Up to Day 5
Frequency of early mobilization performed by one health care provider during mechanical ventilation
次要结局
- Mobilization level(up to Day 5)
- Health care provider assessment(Up to Day 5)
- Anxiety(up to Day 5)
- Muscle wasting(Up to Day5)
- Oxygen consumption during mobilization(Up to Day 5)
- Safety events(Up to Day 5)
- Pain level(up to Day 5)
- Patient satisfaction with mobilization(Up to Day 5)
- Frequency of mobilization(up to Day 5)
- Oesophageal pressure(Up to Day 5)
- Mobilization duration(up to Day 5)
- Inflammatory response(Up to Day 5)
研究者
Stefan J Schaller
Deputy Clinical Director
Charite University, Berlin, Germany
研究点 (2)
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