Head Position in Stroke Trial

NCT ID: NCT01706094

Last Updated: 2015-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Head Position

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The George Institute

OTHER

Sponsor Role: collaborator

Clinica Alemana de Santiago

OTHER

Sponsor Role: lead

Responsible Party

Veronica Olavarria

MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronica V Olavarria, MD, Msc

Role: STUDY_DIRECTOR

Clinica Alemana de Santiago, Chile.

Locations

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, Santiago Metropolitan, Chile

Countries

Australia; Chile

References

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.

Reference Type: DERIVED

PMID: 28581366 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27742914 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26783317 (View on PubMed)

Other Identifiers

HeadPoST1

Identifier Type: -

Identifier Source: org_study_id