<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01706094</url>
  </required_header>
  <id_info>
    <org_study_id>HeadPoST1</org_study_id>
    <nct_id>NCT01706094</nct_id>
  </id_info>
  <brief_title>Head Position in Stroke Trial</brief_title>
  <acronym>HeadPoST-Pilot</acronym>
  <official_title>Head Position in Stroke Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Alemana de Santiago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The George Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinica Alemana de Santiago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A simplest manner to augment cerebral blood flow to irrigate the ischemic penumbra in acute&#xD;
      ischemic stroke could be to place the patient in a 'lying flat' rather than upright head&#xD;
      position. Given uncertainty over the balance of potential modest benefits and risks, and&#xD;
      variability regarding the ideal head position policy for patients with acute ischemic stroke&#xD;
      around the world, reliable randomized evidence is required to standardize clinical practice.&#xD;
&#xD;
      The main objectives of this pilot phase clinical trial are to determine the feasibility,&#xD;
      safety and potential efficacy of a large-scale cluster randomized clinical trial to assess&#xD;
      whether a simple nursing care policy - 'lying flat head position' - provides beneficial&#xD;
      effects as compared to the standard upright head position in patients with acute ischemic&#xD;
      stroke. The main efficacy outcome of the pilot phase is demonstration of increased mean&#xD;
      cerebral blood flow velocity in the flat down compared to the upright head position, as&#xD;
      assessed by transcranial Doppler to the medial cerebral arteries of patients with anterior&#xD;
      circulation infarction. Secondary efficacy objectives are to demonstrate that the flat down&#xD;
      head position improves neurological status at 7 days and disability at 90 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Several lines of investigation indicate there to be potential beneficial effects&#xD;
      of interventions that augment cerebral blood flow (CBF) to irrigate the ischemic penumbra in&#xD;
      acute ischemic stroke. The simplest manner to do this is to place the patient in a 'lying&#xD;
      flat' rather than upright head position. However, any potential benefits on the brain may be&#xD;
      offset by an increased hazard of aspiration pneumonia or exacerbation of cardiac failure in&#xD;
      vulnerable patients. Given uncertainty over the balance of potential modest benefits and&#xD;
      risks, and variability regarding the ideal head position policy for patients with acute&#xD;
      ischemic stroke around the world, reliable randomized evidence is required to standardize&#xD;
      clinical practice.&#xD;
&#xD;
      Aims: The main objectives of this pilot phase clinical trial are to determine the&#xD;
      feasibility, safety and potential efficacy of a large-scale cluster randomized clinical trial&#xD;
      to assess whether a simple nursing care policy - 'lying flat head position' - provides&#xD;
      beneficial effects as compared to the standard upright head position in patients with acute&#xD;
      ischemic stroke. The main efficacy outcome of the pilot phase is demonstration of increased&#xD;
      mean cerebral blood flow velocity (CBFV) in the lying flat head position compared to the&#xD;
      upright head position, as assessed by transcranial Doppler (TCD) to the medial cerebral&#xD;
      arteries of patients with anterior circulation infarction. Secondary efficacy objectives are&#xD;
      to demonstrate that the lying flat head position improves neurological status at 7 days and&#xD;
      disability at 90 days.&#xD;
&#xD;
      Methods: Inclusion criteria include consecutive adult patients with acute ischemic stroke&#xD;
      within 12 hours of onset admitted to participating centers. A cluster (month) method of&#xD;
      randomization to lying flat or upright head position for 48 hours, stratified by site The&#xD;
      primary outcome is change in mean CBFV measured by TCD at 24 hours. Secondary outcomes&#xD;
      include proportion of adverse events at 7 days, distribution of NIHSS at 7 days, and&#xD;
      distribution of mRS disability scale scores at 90 days. Sample size is 46 clusters of 2&#xD;
      patients totaling approximately 92 patients to detect an increase of 8.31 (CI 95% 4.82-12.0)&#xD;
      cm/sec in average CBFV from 30° to 0° head position. This sample size will also allow&#xD;
      detection of that difference with 90% power at a 5% significance level, considering an ICC of&#xD;
      0.037.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increased mean cerebral blood flow velocity (CBFV) in the lying flat compared to the upright head position</measure>
    <time_frame>24 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>proportion of Serious adverse events.</measure>
    <time_frame>7 days</time_frame>
    <description>Assessments of Serious adverse events at 7 days comparing between the two head positioning groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional outcomes</measure>
    <time_frame>7 days and 90 days</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>lying flat head position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Head Position</intervention_name>
    <description>Head position during the first 48 hours from admission of patients with acute ischemic stroke.&#xD;
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.</description>
    <arm_group_label>lying flat head position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or more years old&#xD;
&#xD;
          -  Patients with an acute stroke corresponding to anterior circulation, a CT scan ruling&#xD;
             out intracranial hemorrhage, presenting within 12 hours from symptom onset&#xD;
&#xD;
          -  NIHSS ≥1&#xD;
&#xD;
          -  Susceptible to be tilted down to the flat position or to 30º of the head&#xD;
&#xD;
          -  There is uncertainty about the benefit/harm of head position during a minimum of 24&#xD;
             hours.&#xD;
&#xD;
          -  Informed consent given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to a flat head position (active vomiting, pneumonia, uncontrolled&#xD;
             heart failure)&#xD;
&#xD;
          -  Concomitant medical illness that would interfere with outcome assessment and follow-up&#xD;
&#xD;
          -  Planned decompressive craniectomy or carotid endarterectomy.&#xD;
&#xD;
          -  Absence of sonographic temporal window&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Veronica V Olavarria, MD, Msc</last_name>
    <role>Study Director</role>
    <affiliation>Clinica Alemana de Santiago, Chile.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital regional Dr. Lautaro Navarro Avaria</name>
      <address>
        <city>Punta Arenas</city>
        <state>Region de Magallanes</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Alemana de Santiago</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Chile</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
  </removed_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>December 2, 2015</last_update_submitted>
  <last_update_submitted_qc>December 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinica Alemana de Santiago</investigator_affiliation>
    <investigator_full_name>Veronica Olavarria</investigator_full_name>
    <investigator_title>MD, MSc</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>head position</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01706094
org study id: HeadPoST1
nct id: NCT01706094
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Increased mean cerebral blood flow velocity (CBFV) in the lying flat compared to the upright head position
time frame: 24 hours
description: 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.
measure: proportion of Serious adverse events.
time frame: 7 days
description: Assessments of Serious adverse events at 7 days comparing between the two head positioning groups.
measure: Functional outcomes
time frame: 7 days and 90 days
description: 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.
arm group label: lying flat head position
arm group type: Experimental
description: 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
intervention type: Other
intervention name: Head Position
description: 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.
arm group label: lying flat head position
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Veronica V Olavarria, MD, Msc
role: Study Director
affiliation: Clinica Alemana de Santiago, Chile.
facility: 
facility: 
facility: 
country: Australia
country: Chile
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Clinica Alemana de Santiago
investigator full name: Veronica Olavarria
investigator title: MD, MSc
mesh term: Stroke
mesh term: Ischemic Stroke