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
- 6
- 主要终点
- Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale
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)
结局指标
主要结局
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.
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.
次要结局
- Readmission to the ICU(Up to 30 days)
- Onset of delayed cerebral ischemia (DCI)(3-21 days)
- Type of post-hospital discharge placement(Up to 30 days)
- 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)
- Hospital Anxiety and Depression Scale (HADS)(14 day; 3 months)
研究者
Péter Csécsei
Assistant Professor
University of Pecs