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Head Position in Stroke Trial (HeadPoST) (HeadPoST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162017
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
The George Institute

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Intracerebral Haemorrhage Other: The lying flat (0°) head position for 24 hours Other: The sitting-up (≥30°) head position for 24 hours Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11096 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigator Initiated, International Collaborative, Multicentre, Cluster Crossover, Randomised Controlled Trial to Establish the Effects of Head Positioning on Death or Disability in Patients With Acute Stroke
Actual Study Start Date : March 5, 2015
Actual Primary Completion Date : December 20, 2016
Actual Study Completion Date : January 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The lying flat intervention
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 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).

Active Comparator: The sitting-up intervention
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
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).




Primary Outcome Measures :
  1. Shift ('improvement') in death or disability according to the modified Rankin Scale (mRS) [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Shift in NIH Stroke Scale (NIHSS) score [ Time Frame: 7 days ]
  2. Death [ Time Frame: Within 90 days ]
  3. Length of hospital stay [ Time Frame: up to 90 days ]
  4. European Quality of Life Scale 5 Dimension (EQ-5D) [ Time Frame: 90 days ]
  5. Pneumonia [ Time Frame: Within 48 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162017


Locations
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Australia, New South Wales
The George Institute for Global Health
Sydney, New South Wales, Australia, 2050
Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
Investigators
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Principal Investigator: Craig S Anderson, MD The George Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT02162017    
Other Study ID Numbers: X14-0044
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data is de-identified and therefore individual data cannot be shared
Keywords provided by The George Institute:
Acute ischemic stroke
Acute intracerebral haemorrhage
Head position
Lying flat head position
Sitting up head position
Death
Disability
Clinical trial
Additional relevant MeSH terms:
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Stroke
Cerebral Hemorrhage
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages