Head-of-Bed Positioning in Large Artery Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- National Institute of Health Stroke Scale (NIHSS) change (higher change means more improvement) at day-7 and modified Rankin Score (mRS) at day-7
研究概览
简要总结
Positioning of the patient with hyperacute large artery ischemic stroke (IS) is an important, yet understudied aspect of care that could impact the course of treatment and ultimately clinical outcome. Positioning with the head of bed (HOB) at 0-degree has been shown in small studies to increase cerebral blood flow across arterial occlusion in hyperacute large artery IS, leading to clinical improvement in stroke symptoms. However, this position is believed to increase the risk of aspiration pneumonia. In this randomised clinical trial, the investigators aim to evaluate whether use of 0-degree HOB positioning is associated with clinical stability in hyperacute IS. Investigators hypothesise that patients with large artery occlusions placed in a 0-degree HOB position will experience less early neurologic deterioration within the first 24 hours, than those in the 30-degree or more HOB elevation group. The study aims to confirm the safety of 0-degree-HOB positioning in a large, generalizable sample of hyperacute large artery IS patients. In this randomised trial, patients presenting to the study centers and eligible for intravenous thrombolysis, with (if presenting within 4.5 hours of symptom-onset) or without (presenting between 4.5 to 16 hours of symptom-onset) mechanical thrombectomy. Eligible patients would be randomised to either a zero-degree HOB or an HOB of 30-degree or more. Impact of HOB position on neurological status would be evaluated with serial NIHSS scores. Cerebral hemodynamics would be monitored by transcranial Doppler ultrasonography. Validated criteria would be used to diagnose pneumonia. Functional outcome would be measured by modified Rankin scale (mRS) where the score of 0-2 describe good functional recovery. SPSS version 20 would be used to analyse the data. The trial would provide clinical and hemodynamic data to determine the optimal HOB position in patients with large artery acute ischemic stroke.
详细描述
Positioning of the patient with hyperacute IS is an important, yet understudied aspect of care that could impact the course of treatment and ultimately clinical outcome. Positioning with the head of bed (HOB) at 0-degree has been shown in small studies to increase cerebral blood flow across arterial occlusion in hyperacute large artery IS, leading to clinical improvement in stroke symptoms. On the other hand, small studies have also documented clinical symptom worsening in IS patients when the HOB was elevated to 30-degree or higher.
A recent large cluster randomized trial (HeadPoST) attempted to determine the optimal head position in acute IS, but failed to enrol the patient cohort for which 0-degree head positioning may be beneficial. Findings from HeadPoST have been debated by the stroke neurologists due to some design flaws and enrolment of inappropriate patients to answer this question. In fact, HeadPoST has become a catalyst for conducting a high quality head positioning research in hyperacute large artery IS to definitively answer the question of how best to manage these highly vulnerable patients to ensure stability and prevent symptom worsening.
Mechanisms proposed for clinical improvement at 0-degree-HOB include favorable gravitational arterial flow conditions, recruitment of collateral vessels, and in the case of intravenous thrombolysis, improved clot-lytic interactions augmenting arterial recanalization. Collectively, these mechanisms may support the argument that 0-degree-HOB positioning should be among the first steps taken in large artery hyperacute IS patient management.
This efficacy study aims to determine if 0 degree-HOB positioning in hyperacute IS prevents neurological symptom worsening in large artery occlusion patients. The study will achieve these goals through use of a novel protocol enabling enrolment of consecutive large artery occlusion patients while maintaining compliance with management specified by the guidelines.
This phase III study will utilize a prospective randomized outcome-blinded evaluation (PROBE) approach enrolling consecutive hyperacute large artery IS patients to determine if use of 0-degreeHOB positioning is associated with greater clinical stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Ischemic stroke symptoms consistent with large artery occlusion
- •Baseline non-contrast head CT (or MRI) negative for hemorrhage or mass- effect
- •Evidence of arterial occlusion on standard of care CT angiography or MR angiography or NIHSS 10 or more points
- •Alberta Stroke Program Early Computed Tomography Score [ASPECTS] >6
- •Patients treated with IV-tPA, mechanical thrombectomy or both
- •Pre-stroke baseline modified Rankin Score (mRS) <1
- •Ability to enrol, randomize and begin the intervention within the Emergency Department
排除标准
- •• Pregnancy or suspicion of pregnancy
- •Evidence or suspicion of vomiting any time prior to consent which could predispose to aspiration pneumonia and therefore confound determination of protocol safety
- •Evidence of evolving malignant infarction on admission noncontrast CT (or MRI)
- •Need for intubation with mechanical ventilation, or non-invasive ventilatory support with either bi-level positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP)
- •Inability to tolerate zero-degree positioning due to congestive heart failure, preexisting pneumonia, chronic obstructive pulmonary disease, or other medical condition
- •Admission chest radiograph positive for pleural effusion, pulmonary edema, pneumonia, or other pulmonary condition that may confound determination of protocol safety
- •Abnormal breath sounds on that may confound determination of protocol safety
研究组 & 干预措施
0 degree Head-of-Bed (HOB) position
Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position
干预措施: Allocating head-of-bed position (Biological)
Elevated (30-degree or more) head-of-bed
Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position
干预措施: Allocating head-of-bed position (Biological)
结局指标
主要结局
National Institute of Health Stroke Scale (NIHSS) change (higher change means more improvement) at day-7 and modified Rankin Score (mRS) at day-7
时间窗: day-7
Investigators will analyze the data by dichotomized modified Rankin Score (mRS) 0-2 (good functional outcome) versus 3-6 (poor outcome) as well as mrs 0-1 (excellent outcome) versus mRS 2-6 (unfavorable outcome) as well as ordinal shift across the range of mRS 0-6
National Institute of Health Stroke Scale (NIHSS) change (higher value indicate more improvement) at day-90 and modified Rankin Score (mRS) at day-90
时间窗: day-90
Investigators will analyze the data by dichotomized mRS (0-2 as good functional outcome versus 3-6 as poor outcome), mRS (0-1 as excellent functional outcome versus 2-6 as unfavorable outcome) as well as ordinal shift across entire range of mRS 0-6.
次要结局
未报告次要终点
研究者
VIJAY KUMAR SHARMA
Associate Professor
National University of Singapore