Head Position in Stroke Trial
Head Position in Stroke Trial
A simplest manner to augment cerebral blood flow to irrigate the ischemic penumbra in acute
 ischemic stroke could be to place the patient in a 'lying flat' rather than upright head
 position. 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.

 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 - 'lying flat 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 in the flat down compared to the upright head position, as
 assessed by transcranial Doppler 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.
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 'lying
 flat' 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 - 'lying flat 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 lying flat head position 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 lying flat 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 lying flat 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 46 clusters of 2
 patients totaling approximately 92 patients to detect an increase of 8.31 (CI 95% 4.82-12.0)
 cm/sec in average CBFV from 30° to 0° head position. This sample size will also allow
 detection of that difference with 90% power at a 5% significance level, considering an ICC of
 0.037.
Inclusion Criteria:

 -  Age 18 or more years old

 -  Patients with an acute stroke corresponding to anterior circulation, a CT scan ruling
 out intracranial hemorrhage, presenting within 12 hours from symptom onset

 -  NIHSS ≥1

 -  Susceptible to be tilted down to the flat position or to 30º of the head

 -  There is uncertainty about the benefit/harm of head position during a minimum of 24
 hours.

 -  Informed consent given

 Exclusion Criteria:

 -  Contraindications to a flat head position (active vomiting, pneumonia, uncontrolled
 heart failure)

 -  Concomitant medical illness that would interfere with outcome assessment and follow-up

 -  Planned decompressive craniectomy or carotid endarterectomy.

 -  Absence of sonographic temporal window