Head Position in Stroke Trial (HeadPoST-Pilot)

• Increased mean cerebral blood flow velocity (CBFV) in the flat down compared to the upright head position [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  The main efficacy outcome of the pilot phase is demonstration of increased mean cerebral blood flow velocity (CBFV) in the flat down compared to the upright head position, as assessed by transcranial Doppler (TCD) to the medial cerebral arteries of patients with anterior circulation infarction.
  
  

• proportion of Serious adverse events. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  Assessments of Serious adverse events at 7 days comparing between the two head positioning groups.
  
  

• Functional outcomes [ Time Frame: 7 days and 90 days ] [ Designated as safety issue: No ]
  Secondary efficacy outcome are to demonstrate that the flat down head position improves neurological status at 7 days and disability at 90 days, measured by modified Rankin Scale, in person or by telephone.
  
  

Background: Several lines of investigation indicate there to be potential beneficial effects of interventions that augment cerebral blood flow (CBF) to irrigate the ischemic penumbra in acute ischemic stroke. The simplest manner to do this is to place the patient in a 'flat down' rather than upright head position. However, any potential benefits on the brain may be offset by an increased hazard of aspiration pneumonia or exacerbation of cardiac failure in vulnerable patients. Given uncertainty over the balance of potential modest benefits and risks, and variability regarding the ideal head position policy for patients with acute ischemic stroke around the world, reliable randomized evidence is required to standardize clinical practice.

Aims: The main objectives of this pilot phase clinical trial are to determine the feasibility, safety and potential efficacy of a large-scale cluster randomized clinical trial to assess whether a simple nursing care policy - 'flat down head position' - provides beneficial effects as compared to the standard upright head position in patients with acute ischemic stroke. The main efficacy outcome of the pilot phase is demonstration of increased mean cerebral blood flow velocity (CBFV) in the flat down compared to the upright head position, as assessed by transcranial Doppler (TCD) to the medial cerebral arteries of patients with anterior circulation infarction. Secondary efficacy objectives are to demonstrate that the flat down head position improves neurological status at 7 days and disability at 90 days.

Methods: Inclusion criteria include consecutive adult patients with acute ischemic stroke within 12 hours of onset admitted to participating centers. A cluster (month) method of randomization to flat down or upright head position for 48 hours, stratified by site The primary outcome is change in mean CBFV measured by TCD at 24 hours. Secondary outcomes include proportion of adverse events at 7 days, distribution of NIHSS at 7 days, and distribution of mRS disability scale scores at 90 days. Sample size is 16 clusters of 12 patients totaling approximately 200 patients to detect an increase of 8.3 (±17) cm/sec in average CBFV from 30° to 0° head position. This sample size will also allow detection of a 30% increase in average CBFV from baseline with 80% power at a 5% significance level.