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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Paula Muñoz-Venturelli, Hisatomi Arima, Pablo Lavados, Alejandro Brunser, Bin Peng, Liying Cui, Lily Song, Laurent Billot, Elizabeth Boaden, Maree L. Hackett, Stephane Heritier, Stephen Jan, Sandy Middleton, Verónica V. Olavarría, Joyce Y. Lim, Richard I. Lindley, Emma Heeley, Thompson Robinson, Octavio Pontes-Neto, Lkhamtsoo Natsagdorj, Ruey-Tay Lin, Caroline Watkins, Craig S. Anderson, for the HeadPoST Collaborative Investigators

Published in: Trials | Issue 1/2015

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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: ACTRN12614000483​651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Paula Muñoz-Venturelli
Hisatomi Arima
Pablo Lavados
Alejandro Brunser
Bin Peng
Liying Cui
Lily Song
Laurent Billot
Elizabeth Boaden
Maree L. Hackett
Stephane Heritier
Stephen Jan
Sandy Middleton
Verónica V. Olavarría
Joyce Y. Lim
Richard I. Lindley
Emma Heeley
Thompson Robinson
Octavio Pontes-Neto
Lkhamtsoo Natsagdorj
Ruey-Tay Lin
Caroline Watkins
Craig S. Anderson
for the HeadPoST Collaborative Investigators
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0767-1

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