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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
Muñoz-Venturelli, Paula Arima, Hisatomi Lavados, Pablo Brunser, Alejandro Peng, Bin Cui, Liying Song, Lily Billot, Laurent Boaden, Elizabeth Hackett, Maree L.
Muñoz-Venturelli, Paula
Arima, Hisatomi
Lavados, Pablo
Brunser, Alejandro
Peng, Bin
Cui, Liying
Song, Lily
Billot, Laurent
Boaden, Elizabeth
Hackett, Maree L.
Author
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.
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.
Abstract
Background
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.
Trial registration
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.
Keywords
cluster clinical trial, head position, ischemic stroke, management, nursing care, outcomes, stroke
Date
2015
Type
Journal article
Journal
Trials
Book
Volume
16
Issue
Page Range
1-11
Article Number
Article 256
ACU Department
Nursing Research Institute
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
Published as ‘gold’ (paid) open access
License
CC BY 4.0
File Access
Open