Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 主要终点
- Adverse events during verticalization
研究概览
简要总结
Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. It has been shown that treatment of vertical integration in patients in a vegetative state or minimally conscious state can improve the level of supervision and positive influence on rehabilitation. Therefore, there are sufficient indications that anticipate the treatment of vertical integration, since the phase of hospitalization in ICUs, may improve the functional outcome of the patient.
详细描述
Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
- •Age between 18 and 75 years
- •Glasgow Coma Scale ≤ 8 at entrance in ICUs
- •Adequate respiratory exchange with PaO2/FiO2 ≥ 250
- •Absence of sedation increased
排除标准
- •Major chest trauma with multiple rib fractures and / or pneumothorax
- •Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
- •Cardiovascular instability despite support with amines
- •Intracranial pressure (ICP)> 25 mm / Hg
- •Cerebral Perfusion Pressure (PPC) <60 mm / Hg
- •Severe kidney failure requiring replacement therapy
- •Decompensated liver disease
- •Hematocrit value of ≤ 30%
- •Body weight> 135 kg or height> 210 cm
- •Deep vein thrombosis
结局指标
主要结局
Adverse events during verticalization
时间窗: 21 days: from T1 (first session) to T15 (last session)
It is a composite outcome, assessing the occurence of at least one of the following conditions (component outcomes): Heart rate \<40 bpm or\> 150 bpm; Mean arterial pressure \<70 mmHg; Arterial oxygen saturation \<90%; Onset of ECG anomalies; Traumatic dislodgement of a device;
次要结局
- Changes of hemodynamic parameters(21 days: from T1 (first session) to T15 (last session))