Head Position in Stroke Trial (HeadPoST) - sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial

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dc.contributor.authorMuñoz, Paula
dc.contributor.authorArima, Hisatomi
dc.contributor.authorLavados, Pablo
dc.contributor.authorBrunser, Alejandro
dc.contributor.authorPeng, Bin
dc.contributor.authorCui, Liying
dc.contributor.authorSong, Lily
dc.contributor.authorBillot, Laurent
dc.contributor.authorBoaden, Elizabeth
dc.contributor.authorHackett, Maree
dc.contributor.authorHeritier, Stephane
dc.contributor.authorStephen, Jan
dc.contributor.authorMiddleton, Sandy
dc.contributor.authorOlavarría, Verónica
dc.contributor.authorLim, Joyce
dc.contributor.authorLyndle, Richard
dc.contributor.authorHeeley, Emma
dc.contributor.authorThompson, Robinson
dc.contributor.authorPontes, Octavio
dc.contributor.authorNatsagdorj, Lkhamtsoo
dc.contributor.authorRuey-Tay, Lin
dc.contributor.authorWatkins, Caroline
dc.contributor.authorAnderson, Craig
dc.date.accessioned2016-08-02T14:49:41Z
dc.date.available2016-08-02T14:49:41Z
dc.date.issued2015
dc.description.abstractBACKGROUND: 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. DISCUSSION: HeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke.
dc.identifier.citationMuñoz-Venturelli P, Arima H, Lavados P, Brunser A, Peng B, Cui L, Song L, Billot L, Boaden E, Hackett ML, Heritier S, Jan S, Middleton S, Olavarría VV, Lim JY, Lindley RI, Heeley E, Robinson T, Pontes-Neto O, Natsagdorj L, Lin RT, Watkins C, Anderson CS; HeadPoST Collaborative Investigators. Head Position in Stroke Trial (HeadPoST)--sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial. Trials. 2015 Jun 5;16:256
dc.identifier.urihttp://hdl.handle.net/11447/716
dc.identifier.urihttp://dx.doi.org/10.1186/s13063-015-0767-1
dc.language.isoen_US
dc.publisherBiomed Central Ltd.
dc.subjectCluster clinical trial
dc.subjectHead position
dc.subjectNursing care
dc.subjectStroke
dc.subjectIschemic stroke
dc.titleHead Position in Stroke Trial (HeadPoST) - sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial
dc.typeArtículo

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