Head Position in Stroke Trial (HeadPoST-Pilot)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 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 21, 2015
Last verified: December 2014
  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 '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.


Condition Intervention
Ischemic Stroke
Other: Head Position

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Head Position in Stroke Trial

Further study details as provided by Clinica Alemana de Santiago:

Primary Outcome Measures:
  • Increased mean cerebral blood flow velocity (CBFV) in the lying flat 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 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 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 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.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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 32 clusters of 3 patients totaling approximately 100 patients to detect an increase of 8.31 (±11) 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

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.
  • Absence of sonographic temporal window
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Australia, New South Wales
Royal Prince Alfred Hospital Terminated
Sydney, New South Wales, Australia
Brazil
Hospital de Clinicas de Porto Alegre Withdrawn
Porto Alegre, Rio Grande do Sul, Brazil
Chile
Hospital regional Dr. Lautaro Navarro Avaria Recruiting
Punta Arenas, Region de Magallanes, Chile
Contact: Javier Gaete, MD       javiergaetes@yahoo.com   
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 21, 2015
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by Clinica Alemana de Santiago:
stroke
head position

ClinicalTrials.gov processed this record on March 30, 2015