Clinical trial NCT01706094: Head Position in Stroke Trial
Official title: Head Position in Stroke Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: stroke
head position
Lead sponsor: Clinica Alemana de Santiago
Sponsor class: OTHER
Collaborators: name: The George Institute
First posted: 2012-10-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Increased mean cerebral blood flow velocity (CBFV) in the lying flat compared to the upright head position
timeFrame: 24 hours
Secondary outcomes:
measure: proportion of Serious adverse events.
timeFrame: 7 days
Other outcomes:
measure: Functional outcomes
timeFrame: 7 days and 90 days
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Punta Arenas
country: Chile
facility: Hospital regional Dr. Lautaro Navarro Avaria
state: Region de Magallanes
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
state: Region Metropolitana
Study officials:
affiliation: Clinica Alemana de Santiago, Chile.
name: Veronica V Olavarria, MD, Msc
role: STUDY_DIRECTOR
References:
citation: Olavarria VV, Lavados PM, Munoz-Venturelli P, Gonzalez 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.
citation: Olavarria VV, Arima H, Anderson CS, Brunser A, Munoz-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.
citation: Brunser AM, Munoz Venturelli P, Lavados PM, Gaete J, Martins S, Arima H, Anderson CS, Olavarria 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.