xml: <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/NCT06019078</url>
    </required_header>
    <id_info>
      <org_study_id>H23-01671</org_study_id>
      <nct_id>NCT06019078</nct_id>
    </id_info>
    <brief_title>pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS</brief_title>
    <official_title>Continuous Processed Neurological Monitor to Guide the Management of Sedation for Patients Receiving Mechanical Ventilation: a Prospective Observational Study to Test the Effects on Delirium, Days on a Ventilator, and Post-Intensive Care Syndrome.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fraser Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Victoria</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fraser Health</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this multi-site observational study is to compare delirium rates, days on&#xD;
        mechanical ventilation, and Post Intensive Care Syndrome (PICS) rates in adult Intensive Care&#xD;
        Unit (ICU) patients. The study will examine patients whose sedation and analgesia infusion&#xD;
        titration is managed with both Richmond Agitation and Sedation Scale (RASS) and Processed&#xD;
        Electroencephalography (pEEG) monitoring vs patients who receive RASS monitoring alone.&#xD;
  &#xD;
        The main questions are:&#xD;
  &#xD;
          -  Compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in&#xD;
             conjunction with RASS to guide the management of sedation and analgesic in patients who&#xD;
             are ventilated reduce the average number of delirium days, measured by Intensive Care&#xD;
             Delirium Screening Checklist (ICDSC)?&#xD;
  &#xD;
          -  To determine when compared to RASS monitoring alone if the use of 4 channel pEEG monitor&#xD;
             in conjunction with RASS to guide the management of Intravenous (IV) sedation and&#xD;
             analgesia in ventilated patients reduces the days a patient spends on a mechanical&#xD;
             ventilator when compared to RASS only monitoring from retrospective data.&#xD;
  &#xD;
          -  To determine when compared to RASS monitoring method alone, does the use of 4 channel&#xD;
             pEEG monitor in conjunction with RASS experience lower doses of sedation and analgesia&#xD;
             infusions?&#xD;
  &#xD;
          -  To determine when compared to RASS monitoring method alone, does the use of 4 channel&#xD;
             pEEG monitor in conjunction with RASS experience less incidence and duration of PICS?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to determine the impact of using a 4 channel pEEG monitor to&#xD;
        guide sedation and analgesia management in conjunction with RASS in ventilated patients in&#xD;
        the ICU on length of time patients experience delirium, number of days patients spend on a&#xD;
        ventilator, and incidence of PICS in these same patients.&#xD;
  &#xD;
        Participants who are on a mechanical ventilator and on IV sedation or analgesia will be&#xD;
        placed on a pEEG monitor on admission to ICU.&#xD;
  &#xD;
        Participants will complete a battery of test at discharge, one month post discharge, and&#xD;
        three months post discharge to assess for PICS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Delirium</measure>
      <time_frame>For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.</time_frame>
      <description>Measured by Intensive Care Delirium Screening Checklist (ICDSC). The items include the assessment of: (1) consciousness ( deep sedation/coma, agitation, normal wakefulness, or light sedation); (2) inattention; (3) disorientation; (4) hallucination, delusion, or psychosis; (5) psychomotor agitation or retardation; (6) inappropriate speech or mood; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of delirium and score zero is indicate not in delirium. Each item is scored 0-8.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Days of Mechanical Ventilation</measure>
      <time_frame>From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days.</time_frame>
      <description>Measured at ICU discharge, measured as half days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sedation Infusions (Propofol and/or Midazolam)</measure>
      <time_frame>Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on a sedation infusion is 5 days.</time_frame>
      <description>Rates and dosages of sedation infusions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Combined Sedation and Analgesia Infusions (Dexmedetomidine and/or Ketamine)</measure>
      <time_frame>Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on a combined sedation and analgesic infusion is 3 days.</time_frame>
      <description>Rates and dosages of sedation and analgesic infusions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analgesia Infusions (Fentanyl, Morphine, and/or Hydromorphone)</measure>
      <time_frame>Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on an analgesic infusion is 5 days.</time_frame>
      <description>Rates and dosages of analgesic infusions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Computerized Neurocognitive Screening Vital Signs</measure>
      <time_frame>At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge</time_frame>
      <description>CNS Vital Signs (CNSVS) is a computerized neurocognitive test battery that was developed as a routine clinical screening instrument. It is comprised of seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention and the continuous performance test. Standard Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. CNS Vital Signs standardized have a mean of 100 and a standard deviation is 15. Higher scores are always better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Depression Scale</measure>
      <time_frame>At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)</time_frame>
      <description>The questionnaire comprises seven questions for anxiety and seven questions for depression. For both scales, scores of less than 7 indicate non-cases, score of 8-10 mild case, 11-14 moderate case, and 15-21 severe case.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Impact of Events Scale-Revised</measure>
      <time_frame>At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)</time_frame>
      <description>The IES-R is a validated 22-item self-report scale measuring psychological stress reactions after a major life or traumatic event.1-3Items are rated with reference to the past 7 days on a 5-point scale, ranging from 0 to 4. Three subscale scores are calculated by taking the mean of the item responses: Intrustion (8 items), Avoidance (8 items), and Hyperarousal (6 items). The total score is similarly computed by taking the mean of all 22 items. All scores range from 0 to 4, with higher scores indicating higher event-related distress. Internal consistency estimates(Cronbach's alpha) for all scores range between 0.79 to 0.92.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQol-5D-5L</measure>
      <time_frame>At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)</time_frame>
      <description>Health related quality of life questionnaire EuroQol-5D-5L is used. Five levels are score in 5 dimensions. It is scaled from 0 to 100%. A higher score indicates a higher quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Suppression Ratio</measure>
      <time_frame>From the time pEEG monitoring is initiated until it is discontinued. Average length of time spent on a pEEG monitor is 5 days.</time_frame>
      <description>Percentage of time the patient's brain is in burst suppression. Scored on a numerical scale 0-100%. A lower percentage is better.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Critical Illness</condition>
    <condition>Post Intensive Care Unit Syndrome</condition>
    <condition>Post Intensive Care Syndrome</condition>
    <condition>Mechanical Ventilation Complication</condition>
    <condition>Delirium</condition>
    <condition>Sedative-Related Disorders; Subsequent Encounter</condition>
    <condition>Analgesia</condition>
    <arm_group>
      <arm_group_label>Prospective Cohort</arm_group_label>
      <description>Patients admitted to participating ICUs who meet inclusion criteria monitored by 4 channel pEEG.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Retrospective Cohort</arm_group_label>
      <description>Patients admitted to participating ICUs who meet inclusion criteria not monitored by 4 channel pEEG.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SedLine</intervention_name>
      <description>Continuous 4 channel processed neurological monitor</description>
      <arm_group_label>Prospective Cohort</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult medical and surgical ICU patients .&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Admitted to ICU&#xD;
  &#xD;
            2. Receive mechanical ventilator support during ICU stay&#xD;
  &#xD;
            3. Require IV sedation or analgesic while ventilated&#xD;
  &#xD;
            4. Discharged home from the hospital&#xD;
  &#xD;
            5. Use of pEEG for sedation or analgesic titration&#xD;
  &#xD;
            6. Able to read and speak English&#xD;
  &#xD;
            7. Mechanically ventilated greater than 48 hours&#xD;
  &#xD;
            8. Aged 17 years +1 day or greater&#xD;
  &#xD;
            9. Consent to participate&#xD;
  &#xD;
           10. Participants need a computer with a keyboard, internet access, and email access for&#xD;
               the questionnaires and assessment and be able to use computer and internet.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Deceased during hospitalization&#xD;
  &#xD;
            2. Intubated at a hospital not included within the study &gt; 12 hours&#xD;
  &#xD;
            3. Discharge to rehabilitation facility, long term care, or other outpatient setting&#xD;
  &#xD;
            4. Ventilated greater than 21 days&#xD;
  &#xD;
            5. Inability to provide informed consent&#xD;
  &#xD;
            6. Currently enrolled in any other research study involving drugs or devices&#xD;
  &#xD;
            7. Is unable to be screened for delirium during ICU admission.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>110 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Fiona E Howarth</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fraser Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fiona E Howarth</last_name>
      <phone>6046143694</phone>
      <email>fiona.howarth@fraserhealth.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Joan Bourassa</last_name>
      <phone>6046150041</phone>
      <email>joan.bourassa@fraserhealth.ca</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>criticial illness</keyword>
    <keyword>post intensive care unit syndrome</keyword>
    <keyword>post intensive care syndrome</keyword>
    <keyword>mechanical ventilation complication</keyword>
    <keyword>delirium</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Delirium</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019078
  org study id: H23-01671
  nct id: NCT06019078
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this multi-site observational study is to compare delirium rates, days on
        mechanical ventilation, and Post Intensive Care Syndrome (PICS) rates in adult Intensive Care
        Unit (ICU) patients. The study will examine patients whose sedation and analgesia infusion
        titration is managed with both Richmond Agitation and Sedation Scale (RASS) and Processed
        Electroencephalography (pEEG) monitoring vs patients who receive RASS monitoring alone.
  
        The main questions are:
  
          -  Compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in
             conjunction with RASS to guide the management of sedation and analgesic in patients who
             are ventilated reduce the average number of delirium days, measured by Intensive Care
             Delirium Screening Checklist (ICDSC)?
  
          -  To determine when compared to RASS monitoring alone if the use of 4 channel pEEG monitor
             in conjunction with RASS to guide the management of Intravenous (IV) sedation and
             analgesia in ventilated patients reduces the days a patient spends on a mechanical
             ventilator when compared to RASS only monitoring from retrospective data.
  
          -  To determine when compared to RASS monitoring method alone, does the use of 4 channel
             pEEG monitor in conjunction with RASS experience lower doses of sedation and analgesia
             infusions?
  
          -  To determine when compared to RASS monitoring method alone, does the use of 4 channel
             pEEG monitor in conjunction with RASS experience less incidence and duration of PICS?
  The purpose of this study is to determine the impact of using a 4 channel pEEG monitor to
        guide sedation and analgesia management in conjunction with RASS in ventilated patients in
        the ICU on length of time patients experience delirium, number of days patients spend on a
        ventilator, and incidence of PICS in these same patients.
  
        Participants who are on a mechanical ventilator and on IV sedation or analgesia will be
        placed on a pEEG monitor on admission to ICU.
  
        Participants will complete a battery of test at discharge, one month post discharge, and
        three months post discharge to assess for PICS.
  observational model: Cohort
  time perspective: Prospective
  measure: Delirium
  time frame: For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.
  description: Measured by Intensive Care Delirium Screening Checklist (ICDSC). The items include the assessment of: (1) consciousness ( deep sedation/coma, agitation, normal wakefulness, or light sedation); (2) inattention; (3) disorientation; (4) hallucination, delusion, or psychosis; (5) psychomotor agitation or retardation; (6) inappropriate speech or mood; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of delirium and score zero is indicate not in delirium. Each item is scored 0-8.
  measure: Days of Mechanical Ventilation
  time frame: From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days.
  description: Measured at ICU discharge, measured as half days.
  measure: Sedation Infusions (Propofol and/or Midazolam)
  time frame: Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on a sedation infusion is 5 days.
  description: Rates and dosages of sedation infusions
  measure: Combined Sedation and Analgesia Infusions (Dexmedetomidine and/or Ketamine)
  time frame: Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on a combined sedation and analgesic infusion is 3 days.
  description: Rates and dosages of sedation and analgesic infusions
  measure: Analgesia Infusions (Fentanyl, Morphine, and/or Hydromorphone)
  time frame: Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on an analgesic infusion is 5 days.
  description: Rates and dosages of analgesic infusions
  measure: Computerized Neurocognitive Screening Vital Signs
  time frame: At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge
  description: CNS Vital Signs (CNSVS) is a computerized neurocognitive test battery that was developed as a routine clinical screening instrument. It is comprised of seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention and the continuous performance test. Standard Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. CNS Vital Signs standardized have a mean of 100 and a standard deviation is 15. Higher scores are always better.
  measure: Hospital Anxiety and Depression Scale
  time frame: At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
  description: The questionnaire comprises seven questions for anxiety and seven questions for depression. For both scales, scores of less than 7 indicate non-cases, score of 8-10 mild case, 11-14 moderate case, and 15-21 severe case.
  measure: Impact of Events Scale-Revised
  time frame: At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
  description: The IES-R is a validated 22-item self-report scale measuring psychological stress reactions after a major life or traumatic event.1-3Items are rated with reference to the past 7 days on a 5-point scale, ranging from 0 to 4. Three subscale scores are calculated by taking the mean of the item responses: Intrustion (8 items), Avoidance (8 items), and Hyperarousal (6 items). The total score is similarly computed by taking the mean of all 22 items. All scores range from 0 to 4, with higher scores indicating higher event-related distress. Internal consistency estimates(Cronbach's alpha) for all scores range between 0.79 to 0.92.
  measure: EuroQol-5D-5L
  time frame: At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
  description: Health related quality of life questionnaire EuroQol-5D-5L is used. Five levels are score in 5 dimensions. It is scaled from 0 to 100%. A higher score indicates a higher quality of life.
  measure: Suppression Ratio
  time frame: From the time pEEG monitoring is initiated until it is discontinued. Average length of time spent on a pEEG monitor is 5 days.
  description: Percentage of time the patient's brain is in burst suppression. Scored on a numerical scale 0-100%. A lower percentage is better.
  arm group label: Prospective Cohort
  description: Patients admitted to participating ICUs who meet inclusion criteria monitored by 4 channel pEEG.
  arm group label: Retrospective Cohort
  description: Patients admitted to participating ICUs who meet inclusion criteria not monitored by 4 channel pEEG.
  intervention type: Device
  intervention name: SedLine
  description: Continuous 4 channel processed neurological monitor
  arm group label: Prospective Cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: 110 Years
  last name: Fiona E Howarth
  role: Principal Investigator
  affiliation: Fraser Health
  last name: Fiona E Howarth
  phone: 6046143694
  email: fiona.howarth@fraserhealth.ca
  last name: Joan Bourassa
  phone: 6046150041
  email: joan.bourassa@fraserhealth.ca
  responsible party type: Sponsor
  mesh term: Delirium
  mesh term: Syndrome
  mesh term: Critical Illness
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.