Head Position in Stroke Trial

NCT01706094 | Completed DMC

• 1 other identifier: HeadPoST1
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 3

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.

Conditions

Ischemic Stroke

Keywords

stroke; head position

Outcome Measures

Primary Outcomes (1)

• Increased mean cerebral blood flow velocity (CBFV) in the lying flat compared to the upright head position

  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.

  24 hours

Secondary Outcomes (1)

• proportion of Serious adverse events.

  7 days

Other Outcomes (1)

• Functional outcomes

  7 days and 90 days

Study Arms (1)

lying flat head position

EXPERIMENTAL

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

Interventions

Head Position 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.

lying flat head position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Alemana de Santiago: lead
• The George Institute: collaborator

Study Sites (3)

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Location

Hospital regional Dr. Lautaro Navarro Avaria

Punta Arenas, Region de Magallanes, Chile

Location

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (3)

• 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.

  PMID: 28581366 DERIVED

• 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.

  PMID: 27742914 DERIVED

• 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.

  PMID: 26783317 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Veronica V Olavarria, MD, Msc

  Clinica Alemana de Santiago, Chile.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 15, 2012
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

AU (1); CL (2)