The Investigation of the Impact of Early Mobilization on the Outcome, the Appearance of Early Ischemic Damage, the Functional Status, and the Length of Intensive Care Treatment in Patients With Aneurysmal Subarachnoid Hemorrhage.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score
研究概览
简要总结
The goal of the randomized clinical trial is to examine the effect of early mobilization on primary and secondary outcomes in patients with subarachnoid hemorrhage caused by aneurysm rupture.
Researchers will compare early mobiliziation vs. standrad bed rest care.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 ys
- •Premorbid modified Rankin Scale score of 0-2
- •WFNS I-IV at enrollment
- •Aneurysm occlusion has occurred through open or endovascular means
- •Minimum 24 hours elapsed after aneurysm occlusion
- •The patient has not received thrombolytic therapy
- •Vital parameters are appropriate (mean arterial pressure [MAP] >80 or >110 mm Hg)
- •Signed patient information and consent form
- •Enrollment occurs within 72 hours following ictus
排除标准
- •Age under 18 years
- •Traumatic subarachnoid hemorrhage
- •Incapacitated or limited capacity for action before ictus
- •Confirmed pregnancy
- •Aneurysm multiplicity (unless all aneurysms are treated)
研究组 & 干预措施
Early mobilization
This group is mobilized in the intensive care unit by the institutional physiotherapist with the assistance of specialized personnel. Mobilization is carried out according to the Early Mobilization Protocol (EMP)
Early mobilization protocol:
- Step 1 - Day 1: Bed rest, elevation of the head end to 30°
- Step 2 - Day 2: Bed rest, elevation of the head end to 60°
- Step 3 - Day 3: Bed rest, elevation of the head end to 80°
- Step 4 - Day 4: Sitting on the edge of the bed
- Step 5 - Day 5: Sitting in a chair, standing up
- Step 6 - Day 6: Walking with or without assistance
- Step 7 - Day 7: Walking with or without assistance from today
干预措施: Early mobilization protocol (Behavioral)
Standard bed rest
No early mobilization
干预措施: Standard care (Behavioral)
结局指标
主要结局
Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score
时间窗: 14 day; 3 months
Outcome assessments will include: Modified Rankin Scale Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 3 versus 4 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit.
Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale
时间窗: 14 day; 3 months
Extended Glasgow Outcome Scale Description of the neurological outcome by using extended Glasgow Outcome Score 1. Death 2. Vegetative sate 3. Lower severe disability 4. Upper severe disability 5. Lower moderate disability 6. Upper moderate disability 7. Lower good recovery 8. Upper good recovery Assessment is performed by a blinded investigator of the local study center by personal visit.
次要结局
- Onset of severity of macrovascular vasospasm(Up to 14 days)
- Stay in the Intensive Care Unit (ICU)(Up to 28 days)
- Barthel score(14 day; 3 months)
- Occurrence of infection and its time in the intensive care unit(Up to 30 days)
- Montreal Cognitive Assessment (MoCA)(14 day; 3 months)
- Functional Independence Measure (FIM) scale(14 day)
- Readmission to the ICU(Up to 30 days)
- Hospital Anxiety and Depression Scale (HADS)(14 day; 3 months)
- Onset of delayed cerebral ischemia (DCI)(3-21 days)
- Type of post-hospital discharge placement(Up to 30 days)
研究者
Péter Csécsei
Assistant Professor
University of Pecs