<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/NCT02992717</url>
  </required_header>
  <id_info>
    <org_study_id>3D_CAM</org_study_id>
    <nct_id>NCT02992717</nct_id>
  </id_info>
  <brief_title>Validation of the 3D-CAM to Detect Postoperative Delirium</brief_title>
  <official_title>Validation of the 3D-CAM in the Recovery Room to Detect Postoperative Delirium Compared to Nu-DESC, CAM and DSM-5 Criteria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined&#xD;
      Delirium. The primary objective of this study is to translate the 3D-CAM into the German&#xD;
      language, as well as to validate its use to detect postoperative delirium in the recovery&#xD;
      room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening&#xD;
      Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical&#xD;
      Manual of Mental Disorders).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 200 patients will be enrolled in the study. They will followed up until the&#xD;
      third postoperative day.&#xD;
&#xD;
      Calculation and analysis of demographic and perioperative influencing factors on&#xD;
      postoperative delirium according to routine parameters (age, sex, body height, body weight,&#xD;
      diagnosis, physical status according to the American Society of Anaesthesiologists (ASA PS),&#xD;
      duration of surgery, Physiological and Operative Severity Score (POSSUM), type of anesthesia,&#xD;
      medication against pain and delirium) will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">January 5, 2018</completion_date>
  <primary_completion_date type="Actual">January 4, 2018</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>Sensitivity of the delirium screening/diagnosing tool &quot;3D Confusion Assessment Method (3D-CAM)</measure>
    <time_frame>Up to three days</time_frame>
    <description>Sensitivity of the delirium screening/diagnosing tool &quot;3D Confusion Assessment Method (3D-CAM)&quot; to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity of the delirium screening/diagnosing tool &quot;3D Confusion Assessment Method (3D-CAM)</measure>
    <time_frame>Up to three days</time_frame>
    <description>Specificity of the delirium screening/diagnosing tool &quot;3D Confusion Assessment Method (3D-CAM) to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test Quality Level</measure>
    <time_frame>Up to three days</time_frame>
    <description>Comparison of test Quality level between 3D-CAM, Nu-DESC and CAM to detect POD in the recovery room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of postoperative delirium</measure>
    <time_frame>Up to three days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of stay in recovery room</measure>
    <time_frame>Up to three days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of performance of the delirium testings</measure>
    <time_frame>Up to three days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level</measure>
    <time_frame>Participants will be followed up until the third postoperative day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>Up to three days</time_frame>
    <description>Postoperative complications according to Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay an expected average of 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-house mortality</measure>
    <time_frame>Participants will be followed for the duration of hospital stay an expected average of 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up care</measure>
    <time_frame>Participants will be followed for the duration of hospital stay an expected average of 3 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Postoperative Delirium</condition>
  <arm_group>
    <arm_group_label>Patients undergoing elective general anaesthesia</arm_group_label>
    <description>Male and female adult patients undergoing elective general anaesthesia.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female adult patients undergoing elective general anaesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Male and female patients with age ≥ 18 years&#xD;
&#xD;
          -  Admission to recovery room (RR) or post anaesthesia care unit (PACU) following&#xD;
             elective general anaesthesia and scheduled&#xD;
&#xD;
          -  Inpatient treatment not less than 24 hours.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients with psychiatric diseases and mental retardation&#xD;
&#xD;
          -  Analphabetism&#xD;
&#xD;
          -  Anacusis or Hypoacusis with hearing aid device,&#xD;
&#xD;
          -  Amaurosis&#xD;
&#xD;
          -  Lacking willingness to save and hand out data within the study&#xD;
&#xD;
          -  Accommodation in an institution due to an official or judicial order&#xD;
&#xD;
          -  Patients with unability speaking German or English language&#xD;
&#xD;
          -  Participation in other clinical studies during the study period&#xD;
&#xD;
          -  Coworker in the study site&#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>Claudia Spies, MD, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charite University, Berlin, Germany</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia Spies</investigator_full_name>
    <investigator_title>Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence 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/NCT02992717
org study id: 3D_CAM
nct id: NCT02992717
lead sponsor: 
has dmc: No
The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined
      Delirium. The primary objective of this study is to translate the 3D-CAM into the German
      language, as well as to validate its use to detect postoperative delirium in the recovery
      room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening
      Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical
      Manual of Mental Disorders).
Approximately 200 patients will be enrolled in the study. They will followed up until the
      third postoperative day.

      Calculation and analysis of demographic and perioperative influencing factors on
      postoperative delirium according to routine parameters (age, sex, body height, body weight,
      diagnosis, physical status according to the American Society of Anaesthesiologists (ASA PS),
      duration of surgery, Physiological and Operative Severity Score (POSSUM), type of anesthesia,
      medication against pain and delirium) will be performed.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)
time frame: Up to three days
description: Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)" to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria
measure: Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)
time frame: Up to three days
description: Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM) to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria
measure: Test Quality Level
time frame: Up to three days
description: Comparison of test Quality level between 3D-CAM, Nu-DESC and CAM to detect POD in the recovery room.
measure: Duration of postoperative delirium
time frame: Up to three days
measure: Duration of stay in recovery room
time frame: Up to three days
measure: Duration of performance of the delirium testings
time frame: Up to three days
measure: Pain level
time frame: Participants will be followed up until the third postoperative day
measure: Postoperative complications
time frame: Up to three days
description: Postoperative complications according to Clavien-Dindo classification
measure: Duration of hospital stay
time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
measure: In-house mortality
time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
measure: Follow-up care
time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
arm group label: Patients undergoing elective general anaesthesia
description: Male and female adult patients undergoing elective general anaesthesia.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudia Spies, MD, Prof.
role: Study Director
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
mesh term: Delirium
mesh term: Emergence Delirium
sharing ipd: No