ABSTRACT

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

Condition or disease Intervention/treatment Phase

Ischemic Stroke Other: Head Position Not Applicable

Study Design
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)

Primary Purpose: Treatment

Official Title: Head Position in Stroke Trial
Study Start Date : January 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : October 2015
Experimental and Interventions

Experimental Interventions / Treatment

Experimental: lying flat head position
positioning the head of the bed at zero
degrees during the first 48 hours from
admission of patients with acute ischemic
stroke Active Comparator: upright
position of the head of the bed during 48
hours from admission of patients with
acute ischemic stroke
Other: Head Position
Head position during the first 48 hours
from admission of patients with acute
ischemic stroke.
This trial is organized as a cluster
randomised trial to a policy of flat head
position or upright head position.
Clusters will be months, so that all
patients admitted during a given month
will be positioned either in the flat down
head position (intervention) or upright
head position (control). This will allow
health teams to follow a monthly protocol
without changing position between
patients

Outcome Measures

Primary Outcome Measures :

1. Increased mean cerebral blood flow velocity (CBFV) in the lying flat
compared to the upright head position [ Time Frame: 24 hours ]

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 Outcome Measures :

1. proportion of Serious adverse events. [ Time Frame: 7 days ]

Assessments of Serious adverse events at 7 days comparing between the

two head positioning groups.

Other Outcome Measures:

1. Functional outcomes [ Time Frame: 7 days and 90 days ]

Secondary efficacy outcome are to demonstrate that the lying flat head
position improves neurological status at 7 days and disability at 90 days,
measured by modified Rankin Scale, in person or by telephone.

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Contacts and Locations

Locations

Australia, New South Wales

Royal Prince Alfred Hospital
Sydney, New South Wales, Australia

Hospital regional Dr. Lautaro Navarro Avaria

Punta Arenas, Region de Magallanes, Chile
Clinica Alemana de Santiago
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
Clinica Alemana de Santiago
The George Institute
Sumber Literatur

Olavarría VV, Lavados PM, Muñoz-Venturelli P, González F, Gaete J, Martins S,

Arima H, Anderson CS, Brunser AM. Flat-head positioning increases cerebral blood
flow in anterior circulation acute ischemic stroke. A cluster randomized phase IIb
trial. Int J Stroke. 2018 Aug;13(6):600-611. doi: 10.1177/1747493017711943. Epub
2017 Jun 5.

Olavarría VV, Arima H, Anderson CS, Brunser A, Muñoz-Venturelli P, Billot L,

Lavados PM; HEADPOST Pilot Investigators. Statistical analysis plan of the head
position in acute ischemic stroke trial pilot (HEADPOST pilot). Int J Stroke. 2017
Feb;12(2):211-215. doi: 10.1177/1747493016674955. Epub 2016 Oct 14.

Brunser AM, Muñoz Venturelli P, Lavados PM, Gaete J, Martins S, Arima H,

Anderson CS, Olavarría VV. Head position and cerebral blood flow in acute ischemic
stroke patients: Protocol for the pilot phase, cluster randomized, Head Position in
Acute Ischemic Stroke Trial (HeadPoST pilot). Int J Stroke. 2016 Feb;11(2):253-9.
doi: 10.1177/1747493015620808.