<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/NCT04506788</url>
  </required_header>
  <id_info>
    <org_study_id>68/2012</org_study_id>
    <nct_id>NCT04506788</nct_id>
  </id_info>
  <brief_title>EEG Slow Wave Activity in Hypoxic Brain Injury</brief_title>
  <acronym>BrainICU</acronym>
  <official_title>Assessment of EEG Slow Wave Activity in Comatose Cardiac Arrest Survivors Under Propofol Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cerenion Oy</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oulu</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BrainICU is a prospective observational study investigating the EEG slow wave activity in&#xD;
      comatose cardiac arrest survivors under propofol anesthesia and its association with&#xD;
      neurological outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BrainICU is a prospective observational study investigating the EEG slow wave activity in&#xD;
      comatose cardiac arrest survivors under propofol anesthesia and its association with&#xD;
      neurological outcome. Comatose adult patients admitted to intensive care unit (ICU) after&#xD;
      cardiac arrest are included. Patients with previous neurological disease expected to affect&#xD;
      substantially the EEG are excluded. The patients' relatives are asked for an informed written&#xD;
      consent to participate. In the intensive care, the patients are sedated using continuous&#xD;
      infusion of propofol while receiving temperature management/hypothermia treatment following&#xD;
      the ICUs' common practice. EEG is recorded within the first 24h after ICU admission. If&#xD;
      possible, the recording is repeated on the second and third day i.e. 48h and 72h after ICU&#xD;
      admission, respectively. To induce the maximum effect of propofol on EEG, additional boluses&#xD;
      of propofol during the EEG recording may be given until the burst suppression level is&#xD;
      reached. Slow wave activity is calculated offline from the EEG recordings. The neurological&#xD;
      recovery of the patients is defined 6 months after cardiac arrest from patient documents&#xD;
      and/or by phone call to the patient/ relative using Cerebral Performance Category. After the&#xD;
      follow-up period patient or the relative is also asked to fill a survey (SF-36) to estimate&#xD;
      the health and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2015</start_date>
  <completion_date type="Actual">June 12, 2017</completion_date>
  <primary_completion_date type="Actual">June 12, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EEG slow wave activity</measure>
    <time_frame>0-72 hours</time_frame>
    <description>EEG slow-wave activity determined from the low-frequency (&lt;1 Hz) signal component calculated from the EEG recordings made within 24 hours from ICU admission and repeated, if possible, at 48 hours and 72 hours.</description>
  </primary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Hypoxic-Ischemic Encephalopathy</condition>
  <condition>Cardiac Arrest</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All eligible patients admitted to intensive care in the study units.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Comatose patients admitted to intensive care after cardiac arrest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous neurological disease expected to affect EEG substantially&#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>Jukka Kortelainen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oulu</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oulu University Hospital</name>
      <address>
        <city>Oulu</city>
        <zip>90220</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <reference>
    <citation>Kortelainen J, Vayrynen E, Juuso I, Laurila J, Koskenkari J, Ala-Kokko T. Forehead electrodes sufficiently detect propofol-induced slow waves for the assessment of brain function after cardiac arrest. J Clin Monit Comput. 2020 Feb;34(1):105-110. doi: 10.1007/s10877-019-00282-3. Epub 2019 Feb 20.</citation>
    <PMID>30788811</PMID>
  </reference>
  <reference>
    <citation>Kortelainen J, Vayrynen E, Huuskonen U, Laurila J, Koskenkari J, Backman JT, Alahuhta S, Seppanen T, Ala-Kokko T. Pilot Study of Propofol-induced Slow Waves as a Pharmacologic Test for Brain Dysfunction after Brain Injury. Anesthesiology. 2017 Jan;126(1):94-103. doi: 10.1097/ALN.0000000000001385.</citation>
    <PMID>27749312</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EEG</keyword>
  <keyword>Intensive Care</keyword>
  <keyword>Propofol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04506788
org study id: 68/2012
nct id: NCT04506788
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BrainICU is a prospective observational study investigating the EEG slow wave activity in
      comatose cardiac arrest survivors under propofol anesthesia and its association with
      neurological outcome.
BrainICU is a prospective observational study investigating the EEG slow wave activity in
      comatose cardiac arrest survivors under propofol anesthesia and its association with
      neurological outcome. Comatose adult patients admitted to intensive care unit (ICU) after
      cardiac arrest are included. Patients with previous neurological disease expected to affect
      substantially the EEG are excluded. The patients' relatives are asked for an informed written
      consent to participate. In the intensive care, the patients are sedated using continuous
      infusion of propofol while receiving temperature management/hypothermia treatment following
      the ICUs' common practice. EEG is recorded within the first 24h after ICU admission. If
      possible, the recording is repeated on the second and third day i.e. 48h and 72h after ICU
      admission, respectively. To induce the maximum effect of propofol on EEG, additional boluses
      of propofol during the EEG recording may be given until the burst suppression level is
      reached. Slow wave activity is calculated offline from the EEG recordings. The neurological
      recovery of the patients is defined 6 months after cardiac arrest from patient documents
      and/or by phone call to the patient/ relative using Cerebral Performance Category. After the
      follow-up period patient or the relative is also asked to fill a survey (SF-36) to estimate
      the health and quality of life.
observational model: Case-Only
time perspective: Prospective
measure: EEG slow wave activity
time frame: 0-72 hours
description: EEG slow-wave activity determined from the low-frequency (<1 Hz) signal component calculated from the EEG recordings made within 24 hours from ICU admission and repeated, if possible, at 48 hours and 72 hours.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jukka Kortelainen, MD, PhD
role: Principal Investigator
affiliation: University of Oulu
facility: 
country: Finland
citation: Kortelainen J, Vayrynen E, Juuso I, Laurila J, Koskenkari J, Ala-Kokko T. Forehead electrodes sufficiently detect propofol-induced slow waves for the assessment of brain function after cardiac arrest. J Clin Monit Comput. 2020 Feb;34(1):105-110. doi: 10.1007/s10877-019-00282-3. Epub 2019 Feb 20.
PMID: 30788811
citation: Kortelainen J, Vayrynen E, Huuskonen U, Laurila J, Koskenkari J, Backman JT, Alahuhta S, Seppanen T, Ala-Kokko T. Pilot Study of Propofol-induced Slow Waves as a Pharmacologic Test for Brain Dysfunction after Brain Injury. Anesthesiology. 2017 Jan;126(1):94-103. doi: 10.1097/ALN.0000000000001385.
PMID: 27749312
responsible party type: Sponsor
mesh term: Brain Diseases
mesh term: Brain Ischemia
mesh term: Hypoxia-Ischemia, Brain
mesh term: Heart Arrest
mesh term: Hypoxia
sharing ipd: No