<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/NCT02241655</url>
  </required_header>
  <id_info>
    <org_study_id>201407128</org_study_id>
    <secondary_id>1UH2AG050312-01</secondary_id>
    <nct_id>NCT02241655</nct_id>
  </id_info>
  <brief_title>Electroencephalography Guidance of Anesthesia</brief_title>
  <acronym>ENGAGES</acronym>
  <official_title>Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine whether, compared with usual anesthetic care, an&#xD;
      electroencephalography-guided anesthesia protocol is effective at preventing postoperative&#xD;
      delirium and its downstream effects, and improving postoperative patient reported&#xD;
      health-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium is one of several geriatric syndromes, and is among the most common postoperative&#xD;
      complications, affecting up to 70% of surgical patients older than 60. Delirium is an acute&#xD;
      change that manifests as inattention and inability to think logically, and is deeply&#xD;
      distressing to patients and their families. Based on our surveys of 1,000 surgical patients,&#xD;
      over 30% were worried about experiencing delirium. Delirious patients are unable to&#xD;
      participate effectively in rehabilitation exercises and are susceptible to other geriatric&#xD;
      syndromes, like falls. The occurrence and duration of delirium are associated with longer&#xD;
      intensive care unit and hospital stay, persistent cognitive deterioration, hospital&#xD;
      readmission and increased mortality rate. Additionally, delirium carries a huge social and&#xD;
      economic burden, costing over $60,000 per patient per year. Despite the importance of&#xD;
      delirium to patients and to society, no approach has been proven to prevent postoperative&#xD;
      delirium. Furthermore postoperative delirium is frequently unrecognized, and surgical&#xD;
      patients are not followed systematically after they are discharged from hospital. Without&#xD;
      diagnosing delirium or following patients postoperatively, we are limited in our ability to&#xD;
      test the effectiveness of any intervention to prevent or treat postoperative delirium and its&#xD;
      sequelae. There is mounting evidence that electroencephalography guidance of general&#xD;
      anesthesia can decrease postoperative delirium. Specifically, our group has found that a&#xD;
      suppressed electroencephalogram pattern, which occurs with deep anesthesia, is associated&#xD;
      with increased delirium and death after surgery. The Electroencephalography Guidance of&#xD;
      Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study will therefore compare the&#xD;
      effectiveness of two anesthetic protocols for reduction of postoperative delirium. One&#xD;
      protocol will be based on current standard anesthetic practice, and the other protocol will&#xD;
      be based on electroencephalography guidance. We also expect to determine the impact of the&#xD;
      anesthetic protocols on patient reported outcomes of health-related quality of life. At&#xD;
      Washington University, we have successfully implemented an ambitious study that enrolls&#xD;
      patients at the preoperative assessment clinic, and tracks their health and wellbeing at 30&#xD;
      days and at 1-year postoperatively. This will enable us to assess the consequences of&#xD;
      postoperative delirium and to determine whether anesthetic management can impact patient&#xD;
      reported outcomes, such as health-related quality of life. We shall also explore whether a&#xD;
      multi-component safety intervention for delirious patients prevents downstream adverse&#xD;
      events, like falls. The ENGAGES study - through its structured anesthesia protocols, its&#xD;
      thorough approach to delirium assessment, and its ability to track patients' health and&#xD;
      wellbeing postoperatively - is poised to make a major contribution to the care of elderly&#xD;
      patients who are at risk of postoperative delirium and other adverse outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Delirium</measure>
    <time_frame>5 days</time_frame>
    <description>Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Falls</measure>
    <time_frame>Up to 1 year postoperatively</time_frame>
    <description>The hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>Up to one year postoperatively</time_frame>
    <description>The hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duration of Delirium</measure>
    <time_frame>5 days</time_frame>
    <description>Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews.</description>
  </other_outcome>
  <other_outcome>
    <measure>Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions</measure>
    <time_frame>5 days</time_frame>
    <description>The Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration or Recurrence of Delirium After Hospital Discharge</measure>
    <time_frame>30 days post discharge</time_frame>
    <description>As measured by the FAM-CAM and patient perceptions</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically Relevant Outcomes Associated With Delirium</measure>
    <time_frame>1 year</time_frame>
    <description>Delirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of Patient-reported and Observational Pain Scores</measure>
    <time_frame>5 days</time_frame>
    <description>Given that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative Actigraphy</measure>
    <time_frame>1 day</time_frame>
    <description>Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement.</description>
  </other_outcome>
  <other_outcome>
    <measure>Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments</measure>
    <time_frame>5 days</time_frame>
    <description>Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth</measure>
    <time_frame>1 year</time_frame>
    <description>There is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Delirium Prediction Models</measure>
    <time_frame>5 days</time_frame>
    <description>It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Collaborations With Other Studies</measure>
    <time_frame>5 years</time_frame>
    <description>The ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Severe Delirium</measure>
    <time_frame>5 days</time_frame>
    <description>The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19).</description>
  </other_outcome>
  <other_outcome>
    <measure>EEG and Delirium</measure>
    <time_frame>5 days</time_frame>
    <description>EEG abnormalities have previously been associated with postoperative delirium</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative Actigraphy- Immobile Minutes</measure>
    <time_frame>1 day</time_frame>
    <description>Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1400</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>EEG guided protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will have the standard anesthetic protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>a pragmatic EEG-guided anesthetic protocol</intervention_name>
    <arm_group_label>EEG guided protocol</arm_group_label>
    <other_name>Bispectral Index proprietary processed EEG monitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Patients 60 years old and older,&#xD;
&#xD;
          -  Competent to provide informed consent&#xD;
&#xD;
          -  Undergoing major elective surgery that requires a minimum stay of 2 days&#xD;
             postoperatively (e.g., open cardiac surgery, open thoracic surgery, major vascular&#xD;
             surgery, intra-abdominal surgery, open gynecologic surgery, open urologic surgery,&#xD;
             major orthopedic surgery, open hepato-biliary surgery and major ear, nose and throat&#xD;
             surgery)&#xD;
&#xD;
        Exclusions&#xD;
&#xD;
          -  Neurosurgical procedures will be excluded as surgery on the brain can confound the&#xD;
             outcome (postoperative delirium).&#xD;
&#xD;
          -  Patients with preoperative delirium and patients who are unable to participate&#xD;
             adequately in delirium screening including those who are blind, deaf, or illiterate or&#xD;
             fluent in languages other than English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael S. Avidan, MBBCh, FCASA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric Lenze, MD</last_name>
    <role>Study Director</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nan Lin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan Stark, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Troy Wildes, MD</last_name>
    <role>Study Director</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anke Winter, MD</last_name>
    <role>Study Director</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sharon Inouye, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hebrew Rehabilitation Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arbi Ben Abdallah, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>March 6, 2019</results_first_submitted>
  <results_first_submitted_qc>May 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 18, 2019</results_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Michael Avidan</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Electroencephalography</keyword>
  <keyword>Burst suppression</keyword>
  <keyword>Surgery</keyword>
  <keyword>Delirium</keyword>
  <keyword>Falls</keyword>
  <keyword>Health related quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan: Study protocol with analysis plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 21, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02241655/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Updated Analysis plan for 1 year</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02241655/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>1400 participants were consented to the study168 were not randomized to a study treatment arm (2 died, 49 were ineligible after enrollment, 49 surgery was cancelled, 31 research team missed the surgery, 37 withdrew). A total of 1232 patients were randomized to a study arm.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>EEG Guided Protocol</title>
          <description>Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.&#xD;
a pragmatic EEG-guided anesthetic protocol</description>
        </group>
        <group group_id="P2">
          <title>Control Arm</title>
          <description>Participants will have the standard anesthetic protocol.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="614"/>
                <participants group_id="P2" count="618"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="614"/>
                <participants group_id="P2" count="618"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>EEG Guided Protocol</title>
          <description>Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.&#xD;
a pragmatic EEG-guided anesthetic protocol</description>
        </group>
        <group group_id="B2">
          <title>Control Arm</title>
          <description>Participants will have the standard anesthetic protocol.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="614"/>
            <count group_id="B2" value="618"/>
            <count group_id="B3" value="1232"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.5" lower_limit="65.0" upper_limit="74.7"/>
                    <measurement group_id="B2" value="69.4" lower_limit="64.7" upper_limit="75.8"/>
                    <measurement group_id="B3" value="69.5" lower_limit="64.8" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="282"/>
                    <measurement group_id="B2" value="281"/>
                    <measurement group_id="B3" value="563"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="332"/>
                    <measurement group_id="B2" value="337"/>
                    <measurement group_id="B3" value="669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="555"/>
                    <measurement group_id="B2" value="558"/>
                    <measurement group_id="B3" value="1113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="614"/>
                    <measurement group_id="B2" value="618"/>
                    <measurement group_id="B3" value="1232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.0" lower_limit="25.0" upper_limit="33.0"/>
                    <measurement group_id="B2" value="29.0" lower_limit="25.0" upper_limit="33.0"/>
                    <measurement group_id="B3" value="29.0" lower_limit="25.0" upper_limit="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Attended College</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="198"/>
                    <measurement group_id="B2" value="208"/>
                    <measurement group_id="B3" value="406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lifetime tobacco use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="376"/>
                    <measurement group_id="B2" value="349"/>
                    <measurement group_id="B3" value="725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with a Weekly Alcohol Intake</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="289"/>
                    <measurement group_id="B2" value="297"/>
                    <measurement group_id="B3" value="586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current use of anticonvulsants</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Regular use of opioids</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="154"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Regular use of benzodiazepine</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants with American Society of Anesthesiologist Classification greater than 3</title>
          <description>American Society of Anesthesiologist (ASA) Classification ASA I: Normal Healthy patient ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: a patient with severe systemic disease that is a constant threat to life ASA V: A moribund patient who is not expected to survive without the operation ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                    <measurement group_id="B2" value="221"/>
                    <measurement group_id="B3" value="430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marginal exercise tolerance (METs) less than 4</title>
          <description>The Functional status of the patient can be divided into POOR (&lt; 4 METs,-unable to walk &gt; 2 blocks on level ground without stopping due to symptoms, eating, dressing, toileting, walking indoors, light housework) or MODERATE /EXCELLENT (&gt; 4 METs, -climbing &gt; 1 flight of stairs without stopping, walking up hill &gt; 1-2 blocks, scrubbing floors, moving furniture, golf, bowling, dancing or tennis, running short distance</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="297"/>
                    <measurement group_id="B2" value="295"/>
                    <measurement group_id="B3" value="592"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pulmonary hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Aortic stenosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History or high risk OSA</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="230"/>
                    <measurement group_id="B2" value="219"/>
                    <measurement group_id="B3" value="449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of delirium</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of comorbidities</title>
          <units>Number of comorbidities</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5" lower_limit="3" upper_limit="6"/>
                    <measurement group_id="B2" value="5" lower_limit="3" upper_limit="6"/>
                    <measurement group_id="B3" value="5" lower_limit="3" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of depression</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Personal Health Questionnaire Depression Scale (PHQ-8)</title>
          <description>Assesses current depression. Range 0 to 24. greater than or equal to 10 indicates major depression and greater than or equal to 20 indicates severe major depression.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="B2" value="3" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="B3" value="3.0" lower_limit="0.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Short Blessed Test (SBT)</title>
          <description>The SBT is a screening tool that aids in detecting early cognitive changes associated with dementia disorders. Rage 0 to 28. A score of 0-4 is normal cognition, 5-9 is questionable cognitive impairment, 10 or greater is cognitive impairment consistent with dementia.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B2" value="2" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B3" value="2.0" lower_limit="0.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>8-item Inerview-Differentiate Aging and Dementia (AD8)</title>
          <description>The AD8 is quite sensitive to detecting early cognitive changes associated many common dementing illness including Alzheimer disease, vascular dementia, Lewy body dementia and frontotemporal dementia. Range 0 to 8. A score of 0-1 is normal cognition, 2 or greater cognitive impairment is likely to be present.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="0.0" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Barthel Activies of Daily Living</title>
          <description>Assesses functional independence. Range 0 to 100. Less than 20 indicates totally dependent, 20 to 39 indicates very dependent, 40-59 indicates partially dependent, 60 to 79 indicates minimally dependent, 80 to 100 indicates independent.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15" lower_limit="15" upper_limit="15"/>
                    <measurement group_id="B2" value="15" lower_limit="15" upper_limit="15"/>
                    <measurement group_id="B3" value="15" lower_limit="15" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hand grip strength</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.4" spread="11.0"/>
                    <measurement group_id="B2" value="25.7" spread="10.7"/>
                    <measurement group_id="B3" value="26.1" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Timed up and go</title>
          <units>seconds</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.5" lower_limit="9.2" upper_limit="13.1"/>
                    <measurement group_id="B2" value="11.0" lower_limit="9.4" upper_limit="13.4"/>
                    <measurement group_id="B3" value="10.8" lower_limit="9.3" upper_limit="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lawton Instrumental Activities of Daily Living</title>
          <description>Instrument assesses independent living skills. Range 0 (low function, dependent) to 8 (high function, independent).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8" lower_limit="7" upper_limit="8"/>
                    <measurement group_id="B2" value="8" lower_limit="8" upper_limit="8"/>
                    <measurement group_id="B3" value="8" lower_limit="7" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physical Veterans Rand 12 Item Health Survey (VR-12) Score</title>
          <description>VR-12 is a patient reported global heath measure that is used to assess a patient's overall perspective of their health. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score which then provides an important contrast between the respondents physical and psychological health status. Standardized scale 0 to 100 with 50 representing the population average. A score above 50 is better than the USA average where a score below 50 is worse than the USA average.</description>
          <units>Physical Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.1" spread="11.9"/>
                    <measurement group_id="B2" value="38.2" spread="11.8"/>
                    <measurement group_id="B3" value="38.1" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mental VR-12 score</title>
          <description>VR-12 is a patient reported global heath measure that is used to assess a patient's overall perspective of their health. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score which then provides an important contrast between the respondents physical and psychological health status. Standardized scale 0 to 100 with 50 representing the population average. A score above 50 is better than the USA average where a score below 50 is worse than the USA average.</description>
          <units>Mental Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.6" spread="10.6"/>
                    <measurement group_id="B2" value="53.6" spread="11.0"/>
                    <measurement group_id="B3" value="53.6" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Delirium</title>
        <description>Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.</description>
        <time_frame>5 days</time_frame>
        <population>A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).</population>
        <group_list>
          <group group_id="O1">
            <title>EEG Guided Protocol</title>
            <description>Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.&#xD;
a pragmatic EEG-guided anesthetic protocol</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Participants will have the standard anesthetic protocol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Delirium</title>
          <description>Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.</description>
          <population>A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="604"/>
                <count group_id="O2" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Falls</title>
        <description>The hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls.</description>
        <time_frame>Up to 1 year postoperatively</time_frame>
        <posting_date>12/2020</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Related Quality of Life</title>
        <description>The hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year).</description>
        <time_frame>Up to one year postoperatively</time_frame>
        <posting_date>12/2020</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Duration of Delirium</title>
        <description>Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews.</description>
        <time_frame>5 days</time_frame>
        <population>A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).</population>
        <group_list>
          <group group_id="O1">
            <title>EEG Guided Protocol</title>
            <description>Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.&#xD;
a pragmatic EEG-guided anesthetic protocol</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Participants will have the standard anesthetic protocol.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Delirium</title>
          <description>Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews.</description>
          <population>A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="604"/>
                <count group_id="O2" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions</title>
        <description>The Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients.</description>
        <time_frame>5 days</time_frame>
        <posting_date>07/2020</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Duration or Recurrence of Delirium After Hospital Discharge</title>
        <description>As measured by the FAM-CAM and patient perceptions</description>
        <time_frame>30 days post discharge</time_frame>
        <posting_date>07/2020</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinically Relevant Outcomes Associated With Delirium</title>
        <description>Delirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline.</description>
        <time_frame>1 year</time_frame>
        <posting_date>12/2020</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Comparison of Patient-reported and Observational Pain Scores</title>
        <description>Given that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients.</description>
        <time_frame>5 days</time_frame>
        <posting_date>07/2020</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Postoperative Actigraphy</title>
        <description>Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement.</description>
        <time_frame>1 day</time_frame>
        <population>A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.</population>
        <group_list>
          <group group_id="O1">
            <title>No Delirium</title>
            <description>intact with no delirium throughout postoperative days (POD) 0-5</description>
          </group>
          <group group_id="O2">
            <title>Delirium POD 0-1</title>
            <description>Patients who were delirious POD 0-1</description>
          </group>
          <group group_id="O3">
            <title>Delirium POD 2-5</title>
            <description>Patients who were delirious POD 2-5</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Actigraphy</title>
          <description>Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement.</description>
          <population>A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.</population>
          <units>minutes RMSactivity&gt;0</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134" lower_limit="59" upper_limit="195"/>
                    <measurement group_id="O2" value="101" lower_limit="50" upper_limit="141"/>
                    <measurement group_id="O3" value="93" lower_limit="36" upper_limit="236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments</title>
        <description>Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis.</description>
        <time_frame>5 days</time_frame>
        <population>Patients who were in the ICU, had a nursing CAM-ICU assessment and researcher's delirium assessment were included in this analysis. Agreement between the instruments was calculated using Kappa agreement.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With Nursing ICU Assessment</title>
            <description>Patients who were in the ICU and had a nursing CAM-ICU and researcher's delirium assessment were included in this analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments</title>
          <description>Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis.</description>
          <population>Patients who were in the ICU, had a nursing CAM-ICU assessment and researcher's delirium assessment were included in this analysis. Agreement between the instruments was calculated using Kappa agreement.</population>
          <units>Cohen's kappa coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="562"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" lower_limit="0.29" upper_limit="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth</title>
        <description>There is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study.</description>
        <time_frame>1 year</time_frame>
        <posting_date>12/2020</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Delirium Prediction Models</title>
        <description>It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group.</description>
        <time_frame>5 days</time_frame>
        <population>Covariated included were pre-selected and considered likely to be associated with postoperative delirium.</population>
        <group_list>
          <group group_id="O1">
            <title>Regression Analysis</title>
            <description>The purpose of the logistic regression and adjustment for prognostic covariates was to improve the power of the trial to detect a beneficial effect attributable to the intervention (minimization of electroencephalographic suppression) or to usual anesthesia care on the outcome of interest, postoperative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Delirium Prediction Models</title>
          <description>It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group.</description>
          <population>Covariated included were pre-selected and considered likely to be associated with postoperative delirium.</population>
          <units>odds ratio</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1051"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Guided Group</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" lower_limit="0.30" upper_limit="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" lower_limit="1.02" upper_limit="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" lower_limit="0.71" upper_limit="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" lower_limit="0.28" upper_limit="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Living alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91" lower_limit="0.63" upper_limit="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hearing aid use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" lower_limit="0.52" upper_limit="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No. Comorbidities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" lower_limit="1.01" upper_limit="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASA greater than 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.98" lower_limit="1.27" upper_limit="3.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal exercise tolerance less than 4 METS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" lower_limit="0.86" upper_limit="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Falls in previous 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" lower_limit="0.88" upper_limit="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>History of delirium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.83" lower_limit="1.21" upper_limit="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preoperative PHQ8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" lower_limit="0.99" upper_limit="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preoperative Lawton</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" lower_limit="0.83" upper_limit="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preoperative Barthel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" lower_limit="0.81" upper_limit="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preoperative opioids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" lower_limit="0.88" upper_limit="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preoperative benzodiazepines</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" lower_limit="0.85" upper_limit="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preoperative sodium level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" lower_limit="0.94" upper_limit="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preoperative creatinine level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" lower_limit="0.91" upper_limit="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preoperative hemoglobin level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" lower_limit="0.91" upper_limit="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" lower_limit="0.58" upper_limit="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Collaborations With Other Studies</title>
        <description>The ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites.</description>
        <time_frame>5 years</time_frame>
        <posting_date>01/2025</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Severe Delirium</title>
        <description>The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19).</description>
        <time_frame>5 days</time_frame>
        <population>A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).</population>
        <group_list>
          <group group_id="O1">
            <title>EEG Guided Protocol</title>
            <description>Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.&#xD;
a pragmatic EEG-guided anesthetic protocol</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Participants will have the standard anesthetic protocol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Severe Delirium</title>
          <description>The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19).</description>
          <population>A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="604"/>
                <count group_id="O2" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>EEG and Delirium</title>
        <description>EEG abnormalities have previously been associated with postoperative delirium</description>
        <time_frame>5 days</time_frame>
        <posting_date>07/2020</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Postoperative Actigraphy- Immobile Minutes</title>
        <description>Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile.</description>
        <time_frame>1 day</time_frame>
        <population>A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.</population>
        <group_list>
          <group group_id="O1">
            <title>No Delirium</title>
            <description>intact with no delirium throughout postoperative days (POD) 0-5</description>
          </group>
          <group group_id="O2">
            <title>Delirium POD 0-1</title>
            <description>Patients who were delirious POD 0-1</description>
          </group>
          <group group_id="O3">
            <title>Delirium POD 2-5</title>
            <description>Patients who were delirious POD 2-5</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Actigraphy- Immobile Minutes</title>
          <description>Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile.</description>
          <population>A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.</population>
          <units>minutes RMSactivity=0</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="548" lower_limit="472" upper_limit="625"/>
                    <measurement group_id="O2" value="584" lower_limit="430" upper_limit="620"/>
                    <measurement group_id="O3" value="604" lower_limit="440" upper_limit="683"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during surgery up to 30 days postoperatively</time_frame>
      <group_list>
        <group group_id="E1">
          <title>EEG Guided Protocol</title>
          <description>Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.&#xD;
a pragmatic EEG-guided anesthetic protocol</description>
        </group>
        <group group_id="E2">
          <title>Control Arm</title>
          <description>Participants will have the standard anesthetic protocol.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="124" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="130" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding/anemia requiring unexpected transfusion</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Embolus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Thrombosis without embolus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other hematologic event</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Congestive heart failure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected heart block</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other unexpected abnormal heart rhythms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Unexpected hypo or hyperkelemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected hypo or hypernatremia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other endocrine or metabolic event</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anastomotic leak</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Nausea and/or vomiting</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>GI bleed</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Ileus/bowel obstruction</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other GI event</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylaxis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>UTI</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other immune or infectious event</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anoxic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other neurological event</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Renal failure requiring dialysis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other renal event</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hemothorax</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Respiratory Failures</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other respiratory event</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Other body system event</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected hypotension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other vascular event</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="361" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="345" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding/anemia requiring unexpected transfusion</sub_title>
                <counts group_id="E1" subjects_affected="121" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="126" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Embolus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Thrombosis without embolus</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other hematologic event</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="97" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected heart block</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other unexpected abnormal heart rhythms</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other cardiac event</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Non-cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>unexpected hypo or hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected hypo or hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected hypo or hypernatremia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other endocrine event</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea and/or vomiting</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>GI bleed</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Ileus/bowel obstruction</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other GI event</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Non-anaphylactic allergic reaction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>UTI</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other immune event</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other neurological event</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Renal failure requiring dialysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other renal event</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Hemothorax</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Hypoxemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Respiratory Failures</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other respiratory event</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Other body system event</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Unexpected hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Unexpected hypotension</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="618"/>
              </event>
              <event>
                <sub_title>Other vascular event</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="614"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="618"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Michael Avidan, MBBCh</name_or_title>
      <organization>Washington University</organization>
      <phone>314-332-7265</phone>
      <email>avidanm@wustl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02241655
org study id: 201407128
secondary id: 1UH2AG050312-01
nct id: NCT02241655
lead sponsor: 
collaborator: 
has dmc: Yes
This study aims to determine whether, compared with usual anesthetic care, an
      electroencephalography-guided anesthesia protocol is effective at preventing postoperative
      delirium and its downstream effects, and improving postoperative patient reported
      health-related quality of life.
Delirium is one of several geriatric syndromes, and is among the most common postoperative
      complications, affecting up to 70% of surgical patients older than 60. Delirium is an acute
      change that manifests as inattention and inability to think logically, and is deeply
      distressing to patients and their families. Based on our surveys of 1,000 surgical patients,
      over 30% were worried about experiencing delirium. Delirious patients are unable to
      participate effectively in rehabilitation exercises and are susceptible to other geriatric
      syndromes, like falls. The occurrence and duration of delirium are associated with longer
      intensive care unit and hospital stay, persistent cognitive deterioration, hospital
      readmission and increased mortality rate. Additionally, delirium carries a huge social and
      economic burden, costing over $60,000 per patient per year. Despite the importance of
      delirium to patients and to society, no approach has been proven to prevent postoperative
      delirium. Furthermore postoperative delirium is frequently unrecognized, and surgical
      patients are not followed systematically after they are discharged from hospital. Without
      diagnosing delirium or following patients postoperatively, we are limited in our ability to
      test the effectiveness of any intervention to prevent or treat postoperative delirium and its
      sequelae. There is mounting evidence that electroencephalography guidance of general
      anesthesia can decrease postoperative delirium. Specifically, our group has found that a
      suppressed electroencephalogram pattern, which occurs with deep anesthesia, is associated
      with increased delirium and death after surgery. The Electroencephalography Guidance of
      Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study will therefore compare the
      effectiveness of two anesthetic protocols for reduction of postoperative delirium. One
      protocol will be based on current standard anesthetic practice, and the other protocol will
      be based on electroencephalography guidance. We also expect to determine the impact of the
      anesthetic protocols on patient reported outcomes of health-related quality of life. At
      Washington University, we have successfully implemented an ambitious study that enrolls
      patients at the preoperative assessment clinic, and tracks their health and wellbeing at 30
      days and at 1-year postoperatively. This will enable us to assess the consequences of
      postoperative delirium and to determine whether anesthetic management can impact patient
      reported outcomes, such as health-related quality of life. We shall also explore whether a
      multi-component safety intervention for delirious patients prevents downstream adverse
      events, like falls. The ENGAGES study - through its structured anesthesia protocols, its
      thorough approach to delirium assessment, and its ability to track patients' health and
      wellbeing postoperatively - is poised to make a major contribution to the care of elderly
      patients who are at risk of postoperative delirium and other adverse outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants With Delirium
time frame: 5 days
description: Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.
measure: Postoperative Falls
time frame: Up to 1 year postoperatively
description: The hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls.
measure: Health Related Quality of Life
time frame: Up to one year postoperatively
description: The hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year).
measure: Duration of Delirium
time frame: 5 days
description: Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews.
measure: Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions
time frame: 5 days
description: The Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients.
measure: Duration or Recurrence of Delirium After Hospital Discharge
time frame: 30 days post discharge
description: As measured by the FAM-CAM and patient perceptions
measure: Clinically Relevant Outcomes Associated With Delirium
time frame: 1 year
description: Delirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline.
measure: Comparison of Patient-reported and Observational Pain Scores
time frame: 5 days
description: Given that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients.
measure: Postoperative Actigraphy
time frame: 1 day
description: Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement.
measure: Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments
time frame: 5 days
description: Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis.
measure: Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth
time frame: 1 year
description: There is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study.
measure: Delirium Prediction Models
time frame: 5 days
description: It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group.
measure: Collaborations With Other Studies
time frame: 5 years
description: The ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites.
measure: Number of Participants With Severe Delirium
time frame: 5 days
description: The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19).
measure: EEG and Delirium
time frame: 5 days
description: EEG abnormalities have previously been associated with postoperative delirium
measure: Postoperative Actigraphy- Immobile Minutes
time frame: 1 day
description: Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile.
arm group label: EEG guided protocol
arm group type: Experimental
description: Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
arm group label: Control Arm
arm group type: No Intervention
description: Participants will have the standard anesthetic protocol.
intervention type: Device
intervention name: a pragmatic EEG-guided anesthetic protocol
arm group label: EEG guided protocol
other name: Bispectral Index proprietary processed EEG monitor
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Michael S. Avidan, MBBCh, FCASA
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Eric Lenze, MD
role: Study Director
affiliation: Washington University School of Medicine
last name: Nan Lin, PhD
role: Study Director
affiliation: Washington University School of Medicine
last name: Susan Stark, PhD
role: Study Director
affiliation: Washington University School of Medicine
last name: Troy Wildes, MD
role: Study Director
affiliation: Washington University School of Medicine
last name: Anke Winter, MD
role: Study Director
affiliation: Washington University School of Medicine
last name: Sharon Inouye, MD
role: Study Director
affiliation: Hebrew Rehabilitation Center
last name: Arbi Ben Abdallah, PhD
role: Study Director
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Michael Avidan
investigator title: Professor of Anesthesiology
mesh term: Delirium
mesh term: Anesthetics
provided document: 
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