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Trial registered on ANZCTR


Registration number
ACTRN12614000483651
Ethics application status
Approved
Date submitted
12/04/2014
Date registered
9/05/2014
Date last updated
8/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Head Position in Stroke Trial
Scientific title
An investigator initiated, international collaborative, multicentre, cluster randomised controlled trial to establish the effects of head positioning on death or disability in patients with acute stroke
Secondary ID [1] 284435 0
Nill
Universal Trial Number (UTN)
Trial acronym
HeadPoST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ischaemic stroke 291641 0
Acute intracerebral haemorrhage 291695 0
Condition category
Condition code
Stroke 292024 292024 0 0
Ischaemic
Stroke 292025 292025 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The lying flat (0 degree) head position - the intervention is for all patients to be nursed lying flat (0 degree) immediately after diagnosis of acute stroke is made and to remain in this position for 24 hours. These patients are to have strict bed rest for the first 24 hours after admission to hospital and should be toileted in bed. Patients may be nursed and/or allowed to turn on their side for comfort, feeding and toileting. However, if a patient is very uncomfortable and unable to tolerate this position, they may have their head slightly elevated with a pillow (i.e. no more than 5 degrees). If toileting is impossible in bed, they may sit up or use a commode near the side of the bed for a brief period. Feeding may commence after they have passed an appropriate swallowing screen or assessment; it is possible for patients to eat on their side in the flat position as swallow is an active process that is not dependent on gravity. However, if it is not practical for feeding to be undertaken in the lying flat (0 degree) head position, then a patient may be sat up to 30 degrees for a short time (<30 minutes) for meals. Patients should have no more than 3 breaks in the 30 degrees 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). For patients with dysphagia, the options are: (i) to maintain ‘nil-by-mouth’ for the first 24 hours with hydration maintained by intravenous fluids; and/or (ii) insertion of a nasogastric tube with bolus interval rather than continuous enteral feeding to avoid aspiration. After 24 hours, those patients with minor strokes may have gradual elevation of their head and are allowed to commence gentle graded mobilisation with toilet privileges. Those patients with moderate-to-severe deficits may have the head position maintained for longer and mobilised according to local stroke care guidelines. An appropriately trained person (‘local champion’) will undertake assessments and quality checks on adherence to the randomised intervention protocol on a regular basis and train staff as required to ensure compliance.
Intervention code [1] 289186 0
Treatment: Other
Comparator / control treatment
The sitting-up (greater than 30 degrees) head position - the intervention is for all patients to be nursed with their head elevated (greater than 30 degrees) 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. They may be nursed on their side, while the head position remains at greater than 30 degrees, and have toilet privileges for a short duration with no more than 3 breaks of 30 minutes in a lying down (0 degree) head position or less than 30 degrees head position in the first 24 hours, and none of the breaks are to be grouped together. Feeding may commence after their have passed an appropriate swallowing test. Those patients with minor deficits are allowed gentle mobilisation according to local guidelines. An appropriately trained person (‘local champion’) will undertake assessments and quality checks on adherence to the randomised intervention protocol on a regular basis and train staff as required to ensure compliance.
Control group
Active

Outcomes
Primary outcome [1] 291911 0
Shift (‘improvement’) in death or disability according to the modified Rankin Scale (mRS)
Timepoint [1] 291911 0
90 days
Secondary outcome [1] 307798 0
Shift in NIH Stroke Scale (NIHSS) score
Timepoint [1] 307798 0
7 days
Secondary outcome [2] 307799 0
Death
Timepoint [2] 307799 0
Within 90 days
Secondary outcome [3] 307800 0
Length of hospital stay
Timepoint [3] 307800 0
Hospital discharge or death
Secondary outcome [4] 307801 0
European Quality of Life Scale 5 Dimension (EQ-5D)
Timepoint [4] 307801 0
90 days
Secondary outcome [5] 307802 0
Pneumonia
Hospital acquired pneumonia is defined as pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; and the presence of a new or progressive radiographic infiltrate plus at least two of three clinical features (fever greater than or equal to 38 degrees, leukocytosis or leukopenia, and purulent secretions).
Timepoint [5] 307802 0
Within 48 hours

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The unit of randomisation will be the site (hospital), which will be randomly assigned by a statistician not otherwise involved in the trial to (a) lying flat (0 degree) head position or (b) sitting up (greater than 30 degrees) head position, by country of the site.

The randomised intervention is to be usual nursing care for all stroke patients meeting the study criteria as early as possible from the time of presentation in the ED (or from diagnosis if in-hospital event). The site is required to recruit consecutive stroke cases in the randomised position until the target number of patients is met before immediately crossing over to the other head position. The site will be contacted close to the first intervention target being achieved to prepare for crossing over to the second intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sites will be randomised using a computer-generated random numbers stratified by country of the site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
For a cluster size of 50 AIS patients, and assuming a 5% crossover and 10% drop-out in each hospital, recruitment failure in 10%-15% of hospitals and an intra-cluster correlation coefficient of 0.03, a sample size of 14,000 AIS patients from 140 sites will provide 90% power (alpha=0.05) to detect 16% or greater improvement (shift) (approximate 4% absolute) associated with the lying flat head position in death or disability on the mRS at day 90 in an ordinal logistic regression analysis. Likewise, a sample size of 2,800 ICH patients from 140 sites (average cluster size 10) will provide 90% power (alpha=0.05) to detect 25% or greater improvement (shift) in death or disability associated with sitting up head position. The target of 70 patients in each intervention is derived from 10 patients in the initial learning phase, 50 AIS and 10 ICH. Thus, the overall target number of stroke patients to be recruited at each site is 140 (i.e. 2 x 70).

Analyses will be undertaken at the patient level on an intention-to-treat basis defined by allocated head position at each centre using Generalised Estimating Equations (GEE) or random-effects regression to account for clustering.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2318 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 7994 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 6004 0
China
State/province [1] 6004 0
Country [2] 6005 0
United Kingdom
State/province [2] 6005 0
Country [3] 6006 0
France
State/province [3] 6006 0
Country [4] 6007 0
Chile
State/province [4] 6007 0
Country [5] 6008 0
Brazil
State/province [5] 6008 0
Country [6] 6009 0
Peru
State/province [6] 6009 0

Funding & Sponsors
Funding source category [1] 289086 0
Government body
Name [1] 289086 0
National Health and Medical Research Council (NHMRC)
Address [1] 289086 0
GPO Box 1421 Canberra ACT2601
Country [1] 289086 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
PO Box M201, Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 287747 0
None
Name [1] 287747 0
Address [1] 287747 0
Country [1] 287747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290874 0
Sydney South West Area Health Service Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 290874 0
Research Development Office, Royal Prince Alfred Hospital, Missenden Rod, Camperdown NSW 2050
Ethics committee country [1] 290874 0
Australia
Date submitted for ethics approval [1] 290874 0
29/01/2014
Approval date [1] 290874 0
26/03/2014
Ethics approval number [1] 290874 0
HERC/14/RPAH/49

Summary
Brief summary
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 degree) head position with the sitting up (greater than 30 degrees) 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47714 0
A/Prof Maree Hackett
Address 47714 0
The George Institute for Global Health, PO Box M201 Missenden Rd, Camperdown NSW 2050
Country 47714 0
Australia
Phone 47714 0
+61 2 9993 4500
Fax 47714 0
Email 47714 0
mhackett@georgeinstitute.org.au
Contact person for public queries
Name 47715 0
A/Prof Maree Hackett
Address 47715 0
The George Institute for Global Health, PO Box M201 Missenden Rd, Camperdown NSW 2050
Country 47715 0
Australia
Phone 47715 0
+61 2 9993 4500
Fax 47715 0
Email 47715 0
mhackett@georgeinstitute.org.au
Contact person for scientific queries
Name 47716 0
Prof Craig Anderson
Address 47716 0
The George Institute for Global Health, PO Box M201 Missenden Rd, Camperdown NSW 2050
Country 47716 0
Australia
Phone 47716 0
+61 2 9993 4500
Fax 47716 0
Email 47716 0
canderson@georgeinstitute.org.au

No information has been provided regarding IPD availability
Summary results
No Results