<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/NCT03835156</url>
  </required_header>
  <id_info>
    <org_study_id>REB 18-308</org_study_id>
    <nct_id>NCT03835156</nct_id>
  </id_info>
  <brief_title>Introducing a New EEG Based Index for Monitoring Recall Under Sedation</brief_title>
  <official_title>Introducing a New EEG Based Index for Monitoring Recall Under Sedation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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>
      This is a single centre prospective observational study that will investigate a new EEG based&#xD;
      index in recognizing recall of anesthesia in sedated patients.&#xD;
&#xD;
      Awareness under general anesthesia is a dreadful complication. Various EEG-based technologies&#xD;
      (such as BIS and others) were developed in order to identify this condition during&#xD;
      anesthesia, using an EEG sticker on the forehead measuring the frontal EEG activity. However,&#xD;
      these monitors might be inaccurate due to lack of sensitivity to various hypnotic agents as&#xD;
      well as sensitivity to muscle activity, which might lead to report of deep anesthesia in the&#xD;
      awake patient. Due to the very low prevalence of awareness under general anesthesia it is&#xD;
      difficult to validate or invalidate the effectiveness of these monitors directly.&#xD;
      Nevertheless, sedation often involves much greater prevalence of awareness, which permits to&#xD;
      evaluate identification of recalled awareness with much humbler sample size.&#xD;
&#xD;
      The current available depth of anesthesia EEG based monitors are not effective in sedated&#xD;
      patients since they are susceptible to muscle activity effect, which is present under&#xD;
      sedation.&#xD;
&#xD;
      Based on the current literature in the field of electrophysiology the investigators have&#xD;
      developed the anterior/ posterior (A/P) index (in the range of 0-100) for appreciating the&#xD;
      anesthetic level. It is based on a comparison of anterior brain activity levels to posterior&#xD;
      brain activity levels in response to anesthetic medication. The novelty of the index is stem&#xD;
      from the fact that it is based on analyzing EEG data from only 4 electrodes covering the&#xD;
      frontal and posterior brain activity. The investigators have shown in a proof of concept&#xD;
      study performed in Rambam Hospital, Haifa, Israel that this index is not dependent on muscle&#xD;
      activity thus is the only index that can identify recall in sedated patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification recall, using the new A/P index, in sedated patients</measure>
    <time_frame>2 years</time_frame>
    <description>In this new following study, the investigators suggest to repeat the proof of concept study performed in Rambam Hospital, Israel (NIH trial registration: NCT02938325), with an FDA approved EEG system, with much better signal-to-noise ratio in order to demonstrate the ability to monitor awareness at the 30-seconds resolution scale.&#xD;
The objective of this study will be to demonstrate that the A/P index, which is generated with an FDA approved EEG system, would relate to recall of awareness in sedation, with a better signal to noise ratio whereas a prefrontal based electrophysiological method (BIS) would not relate to recall.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification recall, using a prefrontal based electrophysiological method (BIS) in sedated patients</measure>
    <time_frame>2 years</time_frame>
    <description>Comparing the ability of BIS index to identify patients with recall under sedation, to the new A/P index</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Recall Phenomenon</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All participants will receive detailed oral and printed information about the study and&#xD;
        will sign a written informed consent form prior to study enrollment. Enrollment in the&#xD;
        study is entirely voluntary, and declining to participate will in no way affect the quality&#xD;
        or quantity of care provided to patients. Patients will have the right to withdraw from the&#xD;
        study at any time.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Research group:&#xD;
&#xD;
          1. Patients old 18-80 years&#xD;
&#xD;
          2. ASA I-III criteria&#xD;
&#xD;
          3. Patients undergoing sedation for lithotripsy&#xD;
&#xD;
             Control groups -&#xD;
&#xD;
          4. Control general anesthesia group - Patients ASA I-III criteria, undergoing general&#xD;
             anesthesia for general surgery&#xD;
&#xD;
          5. Control awake group - Awake healthy volunteers,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Lack of informed consent, Age &gt; 80 years, Age &lt; 18 years pregnant women patients who do not&#xD;
        comply with ASA I-III criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andrea Rigamonti, MD</last_name>
    <phone>416-864-5825</phone>
    <email>RigamontiA@smh.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nikhil Mistry, MA</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>42698</phone_ext>
    <email>MistryNi@smh.ca</email>
  </overall_contact_backup>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Unity Health Toronto</investigator_affiliation>
    <investigator_full_name>Andrea Rigamonti</investigator_full_name>
    <investigator_title>Assistant Professor, Medical Director, Trauma Neuro-ICU</investigator_title>
  </responsible_party>
  <!-- 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/NCT03835156
org study id: REB 18-308
nct id: NCT03835156
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single centre prospective observational study that will investigate a new EEG based
      index in recognizing recall of anesthesia in sedated patients.

      Awareness under general anesthesia is a dreadful complication. Various EEG-based technologies
      (such as BIS and others) were developed in order to identify this condition during
      anesthesia, using an EEG sticker on the forehead measuring the frontal EEG activity. However,
      these monitors might be inaccurate due to lack of sensitivity to various hypnotic agents as
      well as sensitivity to muscle activity, which might lead to report of deep anesthesia in the
      awake patient. Due to the very low prevalence of awareness under general anesthesia it is
      difficult to validate or invalidate the effectiveness of these monitors directly.
      Nevertheless, sedation often involves much greater prevalence of awareness, which permits to
      evaluate identification of recalled awareness with much humbler sample size.

      The current available depth of anesthesia EEG based monitors are not effective in sedated
      patients since they are susceptible to muscle activity effect, which is present under
      sedation.

      Based on the current literature in the field of electrophysiology the investigators have
      developed the anterior/ posterior (A/P) index (in the range of 0-100) for appreciating the
      anesthetic level. It is based on a comparison of anterior brain activity levels to posterior
      brain activity levels in response to anesthetic medication. The novelty of the index is stem
      from the fact that it is based on analyzing EEG data from only 4 electrodes covering the
      frontal and posterior brain activity. The investigators have shown in a proof of concept
      study performed in Rambam Hospital, Haifa, Israel that this index is not dependent on muscle
      activity thus is the only index that can identify recall in sedated patients.
observational model: Cohort
time perspective: Prospective
measure: Identification recall, using the new A/P index, in sedated patients
time frame: 2 years
description: In this new following study, the investigators suggest to repeat the proof of concept study performed in Rambam Hospital, Israel (NIH trial registration: NCT02938325), with an FDA approved EEG system, with much better signal-to-noise ratio in order to demonstrate the ability to monitor awareness at the 30-seconds resolution scale.
The objective of this study will be to demonstrate that the A/P index, which is generated with an FDA approved EEG system, would relate to recall of awareness in sedation, with a better signal to noise ratio whereas a prefrontal based electrophysiological method (BIS) would not relate to recall.
measure: Identification recall, using a prefrontal based electrophysiological method (BIS) in sedated patients
time frame: 2 years
description: Comparing the ability of BIS index to identify patients with recall under sedation, to the new A/P index
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea Rigamonti, MD
phone: 416-864-5825
email: RigamontiA@smh.ca
last name: Nikhil Mistry, MA
phone: 416-864-6060
phone ext: 42698
email: MistryNi@smh.ca
responsible party type: Principal Investigator
investigator affiliation: Unity Health Toronto
investigator full name: Andrea Rigamonti
investigator title: Assistant Professor, Medical Director, Trauma Neuro-ICU