Head Position in Stroke Trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000483651
• Date of registration: 09/05/2014
• Prospective Registration: Yes
• Primary sponsor: The George Institute for Global Health
• 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
• Date of first enrolment: 01/09/2014
• Target sample size: 19600
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614000483651.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia, Brazil, Chile, China, France, Peru, United Kingdom

Contacts

• Name: Prof Craig Anderson

• Name: A/Prof Maree Hackett

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Acute ischaemic stroke;Acute intracerebral haemorrhage;
Acute ischaemic stroke
Acute intracerebral haemorrhage

Stroke - Haemorrhagic

Stroke - Ischaemic

Intervention(s)

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-seve

Primary Outcome(s)

Shift (‘improvement’) in death or disability according to the modified Rankin Scale (mRS) [90 days]

Secondary Outcome(s)

Death[Within 90 days]

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).[Within 48 hours]

Length of hospital stay[Hospital discharge or death]

European Quality of Life Scale 5 Dimension (EQ-5D)[90 days]

Shift in NIH Stroke Scale (NIHSS) score [7 days]

Secondary ID(s)

Nill

Source(s) of Monetary Support

National Health and Medical Research Council (NHMRC)

Ethics review

Status: Approved
Approval date:
Contact:

Sydney South West Area Health Service Ethics Review Committee (RPAH Zone)