Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Jun 5:16:256.
doi: 10.1186/s13063-015-0767-1.

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

Paula Muñoz-Venturelli  1   2 , Hisatomi Arima  3 , Pablo Lavados  4   5 , Alejandro Brunser  6 , Bin Peng  7 , Liying Cui  8 , Lily Song  9 , Laurent Billot  10 , Elizabeth Boaden  11 , Maree L Hackett  12   13 , Stephane Heritier  14 , Stephen Jan  15 , Sandy Middleton  16 , Verónica V Olavarría  17 , Joyce Y Lim  18 , Richard I Lindley  19 , Emma Heeley  20 , Thompson Robinson  21 , Octavio Pontes-Neto  22 , Lkhamtsoo Natsagdorj  23 , Ruey-Tay Lin  24 , Caroline Watkins  25   26 , Craig S Anderson  27 ; HeadPoST Collaborative Investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Paula Muñoz-Venturelli et al. Trials. .

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.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Trial schema
See this image and copyright information in PMC

References

    1. Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009;8(4):355–69. doi: 10.1016/S1474-4422(09)70025-0. - DOI - PubMed
    1. Feigin V, Lawes C, Bennett D, Anderson C. Stroke epidemiology: a review of population-based studies of incidence, prevalence, and case-fatality in the late 20th century. Lancet Neurol. 2003;2:43–53. doi: 10.1016/S1474-4422(03)00266-7. - DOI - PubMed
    1. Astrup J, Siesjö BK, Symon L. Thresholds in cerebral ischemia — the ischemic penumbra. Stroke. 1981;12(6):723–5. doi: 10.1161/01.STR.12.6.723. - DOI - PubMed
    1. Eames PJ, Blake MJ, Dawson SL, Panerai RB, Potter JF. Dynamic cerebral autoregulation and beat to beat blood pressure control are impaired in acute ischaemic stroke. J Neurol Neurosurg Psychiatry. 2002;72(4):467–72. - PMC - PubMed
    1. Miyamoto Y, Tamura T, Hiura T, Nakamura T, Higuchi J, Mikami T. The dynamic response of the cardiopulmonary parameters to passive head-up tilt. Jpn J Physiol. 1982;32(2):245–58. doi: 10.2170/jjphysiol.32.245. - DOI - PubMed

Publication types

MeSH terms

Associated data