An Investigator Initiated, International Collaborative, Multicentre, Cluster Crossover, Randomised Controlled Trial to Establish the Effects of Head Positioning on Death or Disability in Patients With Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,096
- 试验地点
- 2
- 主要终点
- Shift ('improvement') in death or disability according to the modified Rankin Scale (mRS)
研究概览
简要总结
This study is an investigator-initiated and conducted, international collaborative, regionally organised, multicentre, prospective, cluster randomised, crossover, blinded outcome assessment study to compare the effectiveness of the lying flat (0°) head position with the sitting up (=30°) head position, in the first 24 hours of admission to hospital for patients with acute stroke, on the poor outcome of death or disability over the subsequent 90 days.
详细描述
Primary aim is to compare the effects of lying flat (0°) head position with sitting up (≥30°) head position applied in the first 24 hours of admission, for patients presenting with acute ischemic stroke (AIS), on the poor outcome of death or disability at 90 days.
Key secondary aim is to determine whether lying flat is superior to sitting up on poor outcome (death and neurological impairment) at 7 days in AIS; and whether sitting up is superior to lying flat on these outcomes in acute intracerebral hemorrhage (ICH).
The hospitals will be required to undertake recruitment of 70 consecutive acute stroke patients of all stroke types, with the power calculations undertaken on a target of 50 AIS patients per site. In the use of consecutive patient recruitment, it is anticipated that an average of 10 ICH patients will also be included within the 70 target patients, before crossing over to the other interventional phase for another 70 target patients recruited. The hospitals will have training, prior to their activation and commencement of the intervention. Data collection at baseline, first 24 hours, discharge/ Day 7, and Day 90 (end of follow-up), will be captured through a web database. Randomised allocation of intervention will be assigned by a statistician not otherwise involved in the study according to a statistical program stratified by the country of the site.
A mixed consent process is proposed, according to local/national rules and regulations, for the following protocol:
- Cluster Guardian consent or appropriate approval (e.g. signed by General Manager or Chief Executive of hospital, or Head of Neurology/Stroke Department) for the randomised head position to be the new usual nursing care for patients with acute stroke;
- With one of the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Adults over 18 years ( the age for adults may vary in different countries)
- •Have a clinical diagnosis of acute stroke (i.e. with a persistent neurological deficit on presentation)
- •Presentation to hospital including in-hospital event and hospital transfers , with a stroke
排除标准
- •Transient ischaemic attack (TIA) (i.e. symptoms fully resolved upon presentation).
- •Definite clinical contraindication or indication to either sitting up head position or lying flat head position.
- •Significant medical condition that takes priority in care and where adherence to the randomised head position is not possible on another ward/department of the hospital.
- •Immediate transfer from the Emergency Department (ED) or admission, to another ward for medical treatment (e.g. for haemodialysis) or surgery (e.g. carotid endarterectomy, haematoma evacuation) where adherence to the randomised head position is not possible
结局指标
主要结局
Shift ('improvement') in death or disability according to the modified Rankin Scale (mRS)
时间窗: 90 days
次要结局
- Length of hospital stay(up to 90 days)
- Pneumonia(Within 48 hours)
- Shift in NIH Stroke Scale (NIHSS) score(7 days)
- Death(Within 90 days)
- European Quality of Life Scale 5 Dimension (EQ-5D)(90 days)