Muñoz-Venturelli Paula, Arima Hisatomi, Lavados Pablo, Brunser Alejandro, Peng Bin, Cui Liying, Song Lily, Billot Laurent, Boaden Elizabeth, Hackett Maree L, Heritier Stephane, Jan Stephen, Middleton Sandy, Olavarría Verónica V, Lim Joyce Y, Lindley Richard I, Heeley Emma, Robinson Thompson, Pontes-Neto Octavio, Natsagdorj Lkhamtsoo, Lin Ruey-Tay, Watkins Caroline, Anderson Craig S
The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia.
Vascular Neurology Program, Neurology Service, Department of Medicine, Clínica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile.
Trials. 2015 Jun 5;16:256. doi: 10.1186/s13063-015-0767-1.
Positioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (≥ 30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke.
METHODS/DESIGN: We plan to conduct an international, cluster randomised, crossover, open, blinded outcome-assessed clinical trial involving 140 study hospitals (clusters) with established acute stroke care programs. Each hospital will be randomly assigned to sequential policies of lying-flat (0°) or sitting-up (≥ 30°) head position as a 'business as usual' stroke care policy during the first 24 hours of admittance. Each hospital is required to recruit 60 consecutive patients with acute ischaemic stroke (AIS), and all patients with acute intracerebral haemorrhage (ICH) (an estimated average of 10), in the first randomised head position policy before crossing over to the second head position policy with a similar recruitment target. After collection of in-hospital clinical and management data and 7-day outcomes, central trained blinded assessors will conduct a telephone disability assessment with the modified Rankin Scale at 90 days. The primary outcome for analysis is a shift (defined as improvement) in death or disability on this scale. For a cluster size of 60 patients with AIS per intervention and with various assumptions including an intracluster correlation coefficient of 0.03, a sample size of 16,800 patients at 140 centres will provide 90 % power (α 0.05) to detect at least a 16 % relative improvement (shift) in an ordinal logistic regression analysis of the primary outcome. The treatment effect will also be assessed in all patients with ICH who are recruited during each treatment study period.
HeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke.
ClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.
在缺血性中风急性期让患者平躺可能会改善恢复情况并减少残疾，但这种可能性尚未在随机试验中得到正式验证。因此，我们启动了中风头部位置试验（HeadPoST），以确定急性中风患者入院后最初24小时内平躺（0°）与坐起（≥30°）头部位置的效果。
方法/设计：我们计划开展一项国际、整群随机、交叉、开放、采用盲法评估结局的临床试验，涉及140家设有急性中风护理项目的研究医院（群组）。每家医院将被随机分配到在入院最初24小时内采用平躺（0°）或坐起（≥30°）头部位置的连续政策，作为“常规”中风护理政策。每家医院需要招募60例连续的急性缺血性中风（AIS）患者，以及在采用第一种随机头部位置政策期间招募的所有急性脑出血（ICH）患者（估计平均10例），然后再转换到具有类似招募目标的第二种头部位置政策。收集住院临床和管理数据以及7天结局后，由中心培训的盲法评估人员将在90天时使用改良Rankin量表进行电话残疾评估。分析的主要结局是该量表上死亡或残疾情况的变化（定义为改善）。对于每次干预有60例AIS患者的群组规模，并在包括群内相关系数为0.03等各种假设下，140个中心的16,800例患者样本量将提供90%的检验效能（α 0.05），以在对主要结局的有序逻辑回归分析中检测到至少16%的相对改善（变化）。治疗效果也将在每个治疗研究期间招募的所有ICH患者中进行评估。
HeadPoST是一项大型国际临床试验，我们将在其中严格评估不同头部位置对急性中风患者的影响。
ClinicalTrials.gov标识符：NCT02162017（注册日期：2014年4月27日）；澳大利亚和新西兰临床试验注册中心标识符：ACTRN12614000483651（注册日期：2014年5月9日）。方案版本和日期：版本2.2，2014年6月19日。
