<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/NCT03287401</url>
  </required_header>
  <id_info>
    <org_study_id>PACUD-EEG</org_study_id>
    <nct_id>NCT03287401</nct_id>
  </id_info>
  <brief_title>Prediction of PACU Delirium Using EEG - German Validation Study</brief_title>
  <acronym>PACUD-EEG</acronym>
  <official_title>Prediction of Postoperative Anesthesia Care Unit Delirium Using Electroencephalography - German Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this observational study is to investigate whether frontal electroencephalogram&#xD;
      analysis is able to predict increased risk for PACU delirium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium in the postoperative anaesthesia care unit (PACU), a special of form of&#xD;
      postoperative delirium, is associated with increased hospital stay and an elevated hospital&#xD;
      re-admission rate. First studies investigating the patients' electroencephalogram (EEG) on&#xD;
      emergence from anaesthesia were able to show that an abrupt change of predominant EEG-rhythm&#xD;
      is associated with an increased rate of PACU delirium. Therefore, it seems possible to use&#xD;
      frontal EEG in order to identify patients being at elevated risk for PACU delirium.&#xD;
&#xD;
      Aim of this observational study is to validate the results of an international collaboration&#xD;
      in a German population of patients undergoing general anaesthesia. EEG in these patients is&#xD;
      recorded from start of anaesthesia until emergence. Rate of PACU delirium is assessed using&#xD;
      the CAM-ICU score 15 and 60 minutes after emergence in the recovery room.&#xD;
&#xD;
      In a pilot study in 626 patients from 2013 to 2015 in 5 international study centres the rate&#xD;
      of PACU delirium was 20%. As it is planned to investigate 5 co-factors using regression&#xD;
      analysis 50 cases of delirium will be necessary for a sufficient analysis. Therefore, in&#xD;
      total 250 patients will be included.&#xD;
&#xD;
      Due to an additional study centre that included 50 patients enrolment of the german&#xD;
      validation group was completed after 200 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">December 6, 2019</completion_date>
  <primary_completion_date type="Actual">December 6, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PACU Delirium</measure>
    <time_frame>Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)</time_frame>
    <description>Detection of delirium in the postoperative anaesthesia care unit using CAM-ICU score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain in the PACU (NRS)</measure>
    <time_frame>Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)</time_frame>
    <description>Pain assessed with numeric rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electroencephalography</measure>
    <time_frame>Pre-induction until emergence from anaesthesia (average of 3 hours)</time_frame>
    <description>Electroencephalography recording</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Patients with general anesthesia</arm_group_label>
    <description>Patients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electroencephalography</intervention_name>
    <description>Patients electroencephalogram will be recorded</description>
    <arm_group_label>Patients with general anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients above the age of 18 years undergoing general anaesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 18 years or older&#xD;
&#xD;
          -  surgery in general anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  general anaesthesia within 30 days before&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Schmid, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum rechts der Isar - Dept. of Anaesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum rechts der Isar Dept. of Anesthesiology</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.</citation>
    <PMID>12799407</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EEG</keyword>
  <keyword>PACU Delirium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03287401
org study id: PACUD-EEG
nct id: NCT03287401
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of this observational study is to investigate whether frontal electroencephalogram
      analysis is able to predict increased risk for PACU delirium.
Delirium in the postoperative anaesthesia care unit (PACU), a special of form of
      postoperative delirium, is associated with increased hospital stay and an elevated hospital
      re-admission rate. First studies investigating the patients' electroencephalogram (EEG) on
      emergence from anaesthesia were able to show that an abrupt change of predominant EEG-rhythm
      is associated with an increased rate of PACU delirium. Therefore, it seems possible to use
      frontal EEG in order to identify patients being at elevated risk for PACU delirium.

      Aim of this observational study is to validate the results of an international collaboration
      in a German population of patients undergoing general anaesthesia. EEG in these patients is
      recorded from start of anaesthesia until emergence. Rate of PACU delirium is assessed using
      the CAM-ICU score 15 and 60 minutes after emergence in the recovery room.

      In a pilot study in 626 patients from 2013 to 2015 in 5 international study centres the rate
      of PACU delirium was 20%. As it is planned to investigate 5 co-factors using regression
      analysis 50 cases of delirium will be necessary for a sufficient analysis. Therefore, in
      total 250 patients will be included.

      Due to an additional study centre that included 50 patients enrolment of the german
      validation group was completed after 200 patients.
observational model: Cohort
time perspective: Prospective
measure: PACU Delirium
time frame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
description: Detection of delirium in the postoperative anaesthesia care unit using CAM-ICU score
measure: Pain in the PACU (NRS)
time frame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
description: Pain assessed with numeric rating scale
measure: Electroencephalography
time frame: Pre-induction until emergence from anaesthesia (average of 3 hours)
description: Electroencephalography recording
arm group label: Patients with general anesthesia
description: Patients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium
intervention type: Device
intervention name: Electroencephalography
description: Patients electroencephalogram will be recorded
arm group label: Patients with general anesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sebastian Schmid, MD
role: Principal Investigator
affiliation: Klinikum rechts der Isar - Dept. of Anaesthesiology
facility: 
country: Germany
citation: Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.
PMID: 12799407
responsible party type: Sponsor
mesh term: Delirium
sharing ipd: No