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Head Position in Stroke Trial

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000483651
Acronym
HeadPoST
Enrollment
19600
Registered
2014-05-09
Start date
2014-09-01
Completion date
2016-06-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 t

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.

Sponsors

The George Institute for Global Health
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 17, 2026