Head Position in Stroke Trial (HeadPoST-Pilot)

This study is currently recruiting participants.
Verified January 2013 by Clinica Alemana de Santiago
Sponsor:
Collaborator:
The George Institute
Information provided by (Responsible Party):
Veronica V Olavarria, Clinica Alemana de Santiago
ClinicalTrials.gov Identifier:
NCT01706094
First received: October 11, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 'flat down' 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 - 'flat down 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 Intervention
Ischemic Stroke
Other: Head Position

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Head Position in Stroke Trial

Resource links provided by NLM:


Further study details as provided by Clinica Alemana de Santiago:

Primary Outcome Measures:
  • Increased mean cerebral blood flow velocity (CBFV) in the flat down compared to the upright head position [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The main efficacy outcome of the pilot phase is demonstration of increased mean cerebral blood flow velocity (CBFV) in the flat down 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:
  • proportion of Serious adverse events. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Assessments of Serious adverse events at 7 days comparing between the two head positioning groups.


Other Outcome Measures:
  • Functional outcomes [ Time Frame: 7 days and 90 days ] [ Designated as safety issue: No ]
    Secondary efficacy outcome are to demonstrate that the flat down head position improves neurological status at 7 days and disability at 90 days, measured by modified Rankin Scale, in person or by telephone.


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: flat down 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.


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 'flat down' 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 - 'flat down 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 flat down 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 flat down 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 flat down 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 16 clusters of 12 patients totaling approximately 200 patients to detect an increase of 8.3 (±17) cm/sec in average CBFV from 30° to 0° head position. This sample size will also allow detection of a 30% increase in average CBFV from baseline with 80% power at a 5% significance level.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706094

Contacts
Contact: Veronica V Olavarria, MD, MSc 56 2 22101111 ext 3557 volavarria@alemana.cl
Contact: Pablo M Lavados, MD, MPH 56 2 22101111 ext 6158 pablolavados@yahoo.com

Locations
Chile
Clinica Alemana de Santiago Recruiting
Santiago, Region Metropolitana, Chile
Contact: Veronica V Olavarria, MD, Msc    56 2 22101111 ext 3557    veroolavarria@yahoo.com   
Contact: Pablo M Lavados, MD, MPH    56 2 22101111 ext 6158    pablolavados@yahoo.com   
Principal Investigator: Pablo M Lavados, MD, MPH, Stroke Unit Director         
Sponsors and Collaborators
Clinica Alemana de Santiago
The George Institute
Investigators
Study Director: Veronica V Olavarria, MD, Msc Clinica Alemana de Santiago, Chile.
  More Information

No publications provided

Responsible Party: Veronica V Olavarria, MD, MSc, Clinica Alemana de Santiago
ClinicalTrials.gov Identifier: NCT01706094     History of Changes
Other Study ID Numbers: HeadPoST1
Study First Received: October 11, 2012
Last Updated: January 15, 2013
Health Authority: Chile: Instituto de Salud Publica de Chile

Keywords provided by Clinica Alemana de Santiago:
stroke
head position

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014