Head Position in Stroke Trial (HeadPoST-Pilot)

December 2, 2015 updated by: Veronica Olavarria, Clinica Alemana de Santiago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Royal Prince Alfred Hospital
  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile
        • Clinica Alemana de Santiago
    • Region de Magallanes
      • Punta Arenas, Region de Magallanes, Chile
        • Hospital regional Dr. Lautaro Navarro Avaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of Serious adverse events.
Time Frame: 7 days
Assessments of Serious adverse events at 7 days comparing between the two head positioning groups.
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Alemana de Santiago

Collaborators

The George Institute

Investigators

  • Study Director: Veronica V Olavarria, MD, Msc, Clinica Alemana de Santiago, Chile.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (ESTIMATE)

October 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HeadPoST1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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