Head Position in Stroke Trial (HeadPoST)

NCT02162017 | Completed DMC

• 1 other identifier: X14-0044
• Study Type: interventional
• Target: 11,096
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an investigator-initiated and conducted, international collaborative, regionally organised, multicentre, prospective, cluster randomised, crossover, blinded outcome assessment study to compare the effectiveness of the lying flat (0°) head position with the sitting up (=30°) head position, in the first 24 hours of admission to hospital for patients with acute stroke, on the poor outcome of death or disability over the subsequent 90 days.

Conditions

Ischemic Stroke; Intracerebral Haemorrhage

Keywords

Acute ischemic stroke; Acute intracerebral haemorrhage; Head position; Lying flat head position; Sitting up head position; Death; Disability; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Shift ('improvement') in death or disability according to the modified Rankin Scale (mRS)

  90 days

Secondary Outcomes (5)

• Shift in NIH Stroke Scale (NIHSS) score

  7 days

• Death

  Within 90 days

• Length of hospital stay

  up to 90 days

• European Quality of Life Scale 5 Dimension (EQ-5D)

  90 days

• Pneumonia

  Within 48 hours

Study Arms (2)

The lying flat intervention

EXPERIMENTAL

Patients in lying flat intervention to be nursed lying flat (0°) immediately after diagnosis of acute stroke is made and to remain in this position for 24 hours

Other: The lying flat (0°) head position for 24 hours

The sitting-up intervention

ACTIVE COMPARATOR

Patients in the sitting up intervention to be nursed with their head elevated (≥30°) by raising the head of the bed (or with extra pillows or wedge) immediately after the diagnosis of acute stroke is made, and to remain in this position for the next 24 hours

Other: The sitting-up (≥30°) head position for 24 hours

Interventions

The lying flat (0°) head position for 24 hours OTHER

The patients should have strict bed rest for the first 24 hours after admission to hospital. They can be nursed in the side-lying position and feeding should be avoided or only given in the ≥30° position to reduce the risk of aspiration, and after a standard swallowing screening. Patients should have no more than 3 breaks of 30 minutes in a 30°head position in the first 24 hours, and none of the breaks are to be grouped together (i.e. no back-to back breaks are permitted).

The lying flat intervention

The sitting-up (≥30°) head position for 24 hours OTHER

For sites that have been randomised to this position, the usual nursing care will be to have patients positioned to sitting-up with the head elevated at 30° or more by raising the head of the bed or use of extra pillows, whatever is the most appropriate, immediately upon presentation to the ED and to remain in that position for 24 hours. Patients should have no more than 3 breaks of 30 minutes in a lying flat head position in the first 24 hours, and none of the breaks are to be grouped together (i.e. no back-to back breaks are permitted).

The sitting-up intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years ( the age for adults may vary in different countries)
• Have a clinical diagnosis of acute stroke (i.e. with a persistent neurological deficit on presentation)
• Presentation to hospital including in-hospital event and hospital transfers , with a stroke

You may not qualify if:

• Transient ischaemic attack (TIA) (i.e. symptoms fully resolved upon presentation).
• Definite clinical contraindication or indication to either sitting up head position or lying flat head position.
• Significant medical condition that takes priority in care and where adherence to the randomised head position is not possible on another ward/department of the hospital.
• Immediate transfer from the Emergency Department (ED) or admission, to another ward for medical treatment (e.g. for haemodialysis) or surgery (e.g. carotid endarterectomy, haematoma evacuation) where adherence to the randomised head position is not possible

Sponsors & Collaborators

• The George Institute: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

The George Institute for Global Health

Sydney, New South Wales, 2050, Australia

Location

Related Publications (10)

• Ouyang M, Roffe C, Billot L, Song L, Wang X, Munoz-Venturelli P, Lavados PM, Robinson T, Middleton S, Olavarria VV, Watkins CL, Lee TH, Brunser AM, Pontes-Neto OM, Hackett ML, Anderson CS. Oxygen desaturation and adverse outcomes in acute stroke: Secondary analysis of the HeadPoST study. Clin Neurol Neurosurg. 2021 Aug;207:106796. doi: 10.1016/j.clineuro.2021.106796. Epub 2021 Jul 6.

  PMID: 34246993 DERIVED

• Wang X, Moullaali TJ, Ouyang M, Billot L, Sandset EC, Song L, Delcourt C, Hackett ML, Watkins CL, Robinson TG, Yang J, Lavados PM, Brunser A, Olavarria VV, Munoz-Venturelli P, Arima H, Middleton S, Pontes-Neto OM, Pandian JD, Rogers K, Anderson CS. Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience. Cerebrovasc Dis. 2021;50(1):78-87. doi: 10.1159/000512608. Epub 2021 Jan 12.

  PMID: 33434907 DERIVED

• Ouyang M, Zhang Y, Wang X, Song L, Billot L, Robinson T, Lavados PM, Arima H, Hackett ML, Olavarria VV, Munoz-Venturelli P, Middleton S, Watkins CL, Pontes-Neto OM, Lee TH, Brunser AM, Anderson CS. Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study. J Neurol Sci. 2020 Dec 15;419:117187. doi: 10.1016/j.jns.2020.117187. Epub 2020 Oct 14.

  PMID: 33075592 DERIVED

• Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.

  PMID: 32640944 DERIVED

• Brunser AM, Ouyang M, Arima H, Lavados PM, Robinson T, Munoz-Venturelli P, Olavarria VV, Billot L, Hackett ML, Song L, Middleton S, Pontes-Neto O, Lee TH, Watkins C, Anderson CS. No benefit of flat head positioning in early moderate-severe acute ischaemic stroke: a HeadPoST study subgroup analysis. Stroke Vasc Neurol. 2020 Dec;5(4):406-409. doi: 10.1136/svn-2020-000387. Epub 2020 Jun 25.

  PMID: 32591406 DERIVED

• Munoz Venturelli P, Li X, Middleton S, Watkins C, Lavados PM, Olavarria VV, Brunser A, Pontes-Neto O, Santos TEG, Arima H, Billot L, Hackett ML, Song L, Robinson T, Anderson CS; HEADPOST (Head Positioning in Acute Stroke Trial) Investigators. Impact of Evidence-Based Stroke Care on Patient Outcomes: A Multilevel Analysis of an International Study. J Am Heart Assoc. 2019 Jul 2;8(13):e012640. doi: 10.1161/JAHA.119.012640. Epub 2019 Jun 25.

  PMID: 31237173 DERIVED

• Minhas JS, Wang X, Lavados PM, Moullaali TJ, Arima H, Billot L, Hackett ML, Olavarria VV, Middleton S, Pontes-Neto O, De Silva HA, Lee TH, Pandian JD, Mead GE, Watkins C, Chalmers J, Anderson CS, Robinson TG; HeadPoST Investigators. Blood pressure variability and outcome in acute ischemic and hemorrhagic stroke: a post hoc analysis of the HeadPoST study. J Hum Hypertens. 2019 May;33(5):411-418. doi: 10.1038/s41371-019-0193-z. Epub 2019 Mar 20.

  PMID: 30894658 DERIVED

• Billot L, Woodward M, Arima H, Hackett ML, Munoz Venturelli P, Lavados PM, Brunser A, Peng B, Cui L, Song L, Heritier S, Jan S, Middleton S, Olavarria VV, Lim J, Robinson T, Pontes-Neto O, Watkins C, Anderson CS. Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial. Int J Stroke. 2017 Aug;12(6):667-670. doi: 10.1177/1747493017701943. Epub 2017 Mar 24.

  PMID: 28730950 DERIVED

• Anderson CS, Arima H, Lavados P, Billot L, Hackett ML, Olavarria VV, Munoz Venturelli P, Brunser A, Peng B, Cui L, Song L, Rogers K, Middleton S, Lim JY, Forshaw D, Lightbody CE, Woodward M, Pontes-Neto O, De Silva HA, Lin RT, Lee TH, Pandian JD, Mead GE, Robinson T, Watkins C; HeadPoST Investigators and Coordinators. Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke. N Engl J Med. 2017 Jun 22;376(25):2437-2447. doi: 10.1056/NEJMoa1615715.

  PMID: 28636854 DERIVED

• Munoz-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, Olavarria 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. doi: 10.1186/s13063-015-0767-1.

  PMID: 26040944 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Death

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig S Anderson, MD

  The George Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2014
• First Posted: June 12, 2014
• Study Start: March 5, 2015
• Primary Completion: December 20, 2016
• Study Completion: January 13, 2017
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)