xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05992818</url>
    </required_header>
    <id_info>
      <org_study_id>2022/2132</org_study_id>
      <nct_id>NCT05992818</nct_id>
    </id_info>
    <brief_title>Comparison of DRS-R-98 and 3D-CAM in the Assessment of Postoperative Delirium in Elderly Patients</brief_title>
    <official_title>Comparison of DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute Diagnostic Assessment for CAM-Confusion Assessment Method-defined Delirium) in the Assessment of Postoperative Delirium in Elderly Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University</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>
        Postoperative delirium (POD) is a transient and usually fully reversible altered state of&#xD;
        consciousness that develops acutely or subacutely after surgery, characterized by widespread,&#xD;
        daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania),&#xD;
        hypoactive (depressive) and mixed type. It has been shown to be associated with increased&#xD;
        morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative&#xD;
        period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46%&#xD;
        in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the&#xD;
        literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery&#xD;
        disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic,&#xD;
        opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte&#xD;
        disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk&#xD;
        factors associated with delirium. This condition, which has a multifactorial etiology, is&#xD;
        often unrecognized, unpreventable, untreatable and leads to increased morbidity and&#xD;
        mortality. Therefore, it is important to recognize delirium that develops in the&#xD;
        postoperative period and to perform the necessary interventions.&#xD;
  &#xD;
        There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient&#xD;
        under many sub-headings such as orientation, memory, attention, visual and spatial ability.&#xD;
  &#xD;
        The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of&#xD;
        Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98&#xD;
        (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for&#xD;
        CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these&#xD;
        tests are useful for the clinician in the diagnosis of delirium.&#xD;
  &#xD;
        The aim of the study is to compare the DRS-R-98 and 3D-CAM tests used in the assessment of&#xD;
        POD, and to evaluate their feasibility and the power detecting delirium.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative delirium (POD) is a transient and usually fully reversible altered state of&#xD;
        consciousness that develops acutely or subacutely after surgery, characterized by widespread,&#xD;
        daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania),&#xD;
        hypoactive (depressive) and mixed type. It has been shown to be associated with increased&#xD;
        morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative&#xD;
        period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46%&#xD;
        in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the&#xD;
        literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery&#xD;
        disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic,&#xD;
        opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte&#xD;
        disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk&#xD;
        factors associated with delirium. This condition, which has a multifactorial etiology, is&#xD;
        often unrecognized, unpreventable, untreatable and leads to increased morbidity and&#xD;
        mortality. Therefore, it is important to recognize delirium that develops in the&#xD;
        postoperative period and to perform the necessary interventions.&#xD;
  &#xD;
        There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient&#xD;
        under many sub-headings such as orientation, memory, attention, visual and spatial ability.&#xD;
        The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of&#xD;
        Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98&#xD;
        (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for&#xD;
        CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these&#xD;
        tests are useful for the clinician in the diagnosis of delirium. The aim of the study is to&#xD;
        compare the DRS-R-98 and 3D-CAM tests used in the assessment of POD, and to evaluate their&#xD;
        feasibility and the power detecting delirium.&#xD;
  &#xD;
        After obtaining ethics committee approval, all patients who undergo orthopedic, urological,&#xD;
        general surgery, thoracic and vascular surgery operations in the Istanbul Faculty of&#xD;
        Medicine, above 65 years old, with an operation duration longer than 60 minutes will include&#xD;
        in this study. Patients who are re-operated, require re-intubation or withdraw their consent&#xD;
        will be excluded from the study. This study is planned as an observational, prospective&#xD;
        study. Demographic information such as age, gender, height, weight, comorbidities, duration&#xD;
        of operation and anesthesia, postoperative pain level, anesthesia and analgesia management,&#xD;
        intensive care and hospitalization periods will be recorded from their files. On&#xD;
        postoperative day 1, delirium development will be evaluated with DSM-5 diagnostic criteria.&#xD;
        All patients will also be evaluated by another physician with both DRS-R-98 and 3D-CAM tests.&#xD;
        The same tests will be repeated on postoperative day 2.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 16, 2023</start_date>
    <completion_date type="Anticipated">December 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 20, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>2 Days</target_duration>
    <primary_outcome>
      <measure>Comparing the tests (3D-CAM and DRS-R-98) in the assessment of postoperative delirium.</measure>
      <time_frame>2 days</time_frame>
      <description>the specificity, sensitivity and consistency of 3D-CAM and DRS-R-98 tests used in the evaluation of postoperative delirium. Both tests include sections that assess the patient's responses to the questions asked and also the practitioner's observations</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>incidence of postoperative delirium</measure>
      <time_frame>2 days</time_frame>
      <description>determine the incidence of postoperative delirium</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of hospital stay</measure>
      <time_frame>2-21 days</time_frame>
      <description>examine the relationship between delirium and hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative pain assessment with Numeric Rating Scale (NRS)</measure>
      <time_frame>2 days</time_frame>
      <description>Numerical rating scales (NRSs) are the simplest and most commonly used scales.The numerical scale is most commonly 0 to 10, with 0 being &quot;no pain&quot; and 10 being &quot;the worst pain imaginable.&quot;</description>
    </secondary_outcome>
    <enrollment type="Anticipated">270</enrollment>
    <condition>Postoperative Delirium</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>comparing DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium) tests to assess postoperative delirium</intervention_name>
      <description>determine the test that is more effective and practical in the assessment of POD</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          ≥ 65 years male and female orthopedic, urological, thoracic, vascular (off-pump) and&#xD;
          general surgery operations&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  orthopedic, urological, thoracic, vascular and general surgery operations&#xD;
  &#xD;
            -  Emergency and elective surgery&#xD;
  &#xD;
            -  Patients with voluntary consent&#xD;
  &#xD;
            -  Patients aged ≥ 65 years&#xD;
  &#xD;
            -  Surgeries longer than 60 minutes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt; 65 years old patients&#xD;
  &#xD;
            -  Operations that take less than 60 minutes&#xD;
  &#xD;
            -  Patients who do not speak Turkish&#xD;
  &#xD;
            -  Patients who cannot legally give consent (eg dementia)&#xD;
  &#xD;
            -  Patients without consent&#xD;
  &#xD;
            -  Outpatient surgeries&#xD;
  &#xD;
            -  Reoperated or reintubated patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zerrin SUNGUR, Prof Dr</last_name>
      <role>Study Chair</role>
      <affiliation>Istanbul University Istanbul Faculty of Medicine Department of Anesthesiology and Reanimation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tuğçe DİNÇ DOĞAN, MD</last_name>
      <phone>00905379412059</phone>
      <email>tugce_dinc@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ozlem TURHAN, MD</last_name>
      <phone>00905055381923</phone>
      <email>ozlemturhan6@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istanbul Faculty of Medicine</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Özlem Turhan, MD</last_name>
        <phone>+905055381923</phone>
        <email>ozlemturhan6@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Tuğçe DİNÇ DOĞAN, MD</last_name>
        <phone>00905379412059</phone>
        <email>tugce_dinc@hotmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Oh ST, Park JY. Postoperative delirium. Korean J Anesthesiol. 2019 Feb;72(1):4-12. doi: 10.4097/kja.d.18.00073.1. Epub 2018 Aug 24.</citation>
      <PMID>30139213</PMID>
    </results_reference>
    <results_reference>
      <citation>Janssen TL, Alberts AR, Hooft L, Mattace-Raso F, Mosk CA, van der Laan L. Prevention of postoperative delirium in elderly patients planned for elective surgery: systematic review and meta-analysis. Clin Interv Aging. 2019 Jun 19;14:1095-1117. doi: 10.2147/CIA.S201323. eCollection 2019.</citation>
      <PMID>31354253</PMID>
    </results_reference>
    <results_reference>
      <citation>American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5Ⓡ). 5th ed. Arlington, American Psychiatric Association Publishing. 2013, pp 596-601.</citation>
    </results_reference>
    <results_reference>
      <citation>Palihnich K, Inouye SK, Marcantonio ER. The 3D CAM Training Manual for Research. 2014; Boston: Hospital Elder Life Program</citation>
    </results_reference>
    <results_reference>
      <citation>Cinar MA,Ozmenler KN ,Ozsahin A ,Trzepacz Paula T. Dusunen Adam The Journal of Psychiatry and Neurological Sciences 2014; 3(27): 186-193 DOI: 10.5350/DAJPN2014270301</citation>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University</investigator_affiliation>
      <investigator_full_name>Ozlem Turhan</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Elderly patients</keyword>
    <keyword>DRS-R-98(The Delirium Rating Scale--Revised-98)</keyword>
    <keyword>3D-CAM</keyword>
    <keyword>delirium</keyword>
    <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>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05992818
  org study id: 2022/2132
  nct id: NCT05992818
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Postoperative delirium (POD) is a transient and usually fully reversible altered state of
        consciousness that develops acutely or subacutely after surgery, characterized by widespread,
        daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania),
        hypoactive (depressive) and mixed type. It has been shown to be associated with increased
        morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative
        period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46%
        in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the
        literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery
        disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic,
        opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte
        disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk
        factors associated with delirium. This condition, which has a multifactorial etiology, is
        often unrecognized, unpreventable, untreatable and leads to increased morbidity and
        mortality. Therefore, it is important to recognize delirium that develops in the
        postoperative period and to perform the necessary interventions.
  
        There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient
        under many sub-headings such as orientation, memory, attention, visual and spatial ability.
  
        The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of
        Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98
        (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for
        CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these
        tests are useful for the clinician in the diagnosis of delirium.
  
        The aim of the study is to compare the DRS-R-98 and 3D-CAM tests used in the assessment of
        POD, and to evaluate their feasibility and the power detecting delirium.
  Postoperative delirium (POD) is a transient and usually fully reversible altered state of
        consciousness that develops acutely or subacutely after surgery, characterized by widespread,
        daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania),
        hypoactive (depressive) and mixed type. It has been shown to be associated with increased
        morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative
        period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46%
        in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the
        literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery
        disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic,
        opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte
        disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk
        factors associated with delirium. This condition, which has a multifactorial etiology, is
        often unrecognized, unpreventable, untreatable and leads to increased morbidity and
        mortality. Therefore, it is important to recognize delirium that develops in the
        postoperative period and to perform the necessary interventions.
  
        There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient
        under many sub-headings such as orientation, memory, attention, visual and spatial ability.
        The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of
        Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98
        (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for
        CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these
        tests are useful for the clinician in the diagnosis of delirium. The aim of the study is to
        compare the DRS-R-98 and 3D-CAM tests used in the assessment of POD, and to evaluate their
        feasibility and the power detecting delirium.
  
        After obtaining ethics committee approval, all patients who undergo orthopedic, urological,
        general surgery, thoracic and vascular surgery operations in the Istanbul Faculty of
        Medicine, above 65 years old, with an operation duration longer than 60 minutes will include
        in this study. Patients who are re-operated, require re-intubation or withdraw their consent
        will be excluded from the study. This study is planned as an observational, prospective
        study. Demographic information such as age, gender, height, weight, comorbidities, duration
        of operation and anesthesia, postoperative pain level, anesthesia and analgesia management,
        intensive care and hospitalization periods will be recorded from their files. On
        postoperative day 1, delirium development will be evaluated with DSM-5 diagnostic criteria.
        All patients will also be evaluated by another physician with both DRS-R-98 and 3D-CAM tests.
        The same tests will be repeated on postoperative day 2.
  observational model: Cohort
  time perspective: Prospective
  measure: Comparing the tests (3D-CAM and DRS-R-98) in the assessment of postoperative delirium.
  time frame: 2 days
  description: the specificity, sensitivity and consistency of 3D-CAM and DRS-R-98 tests used in the evaluation of postoperative delirium. Both tests include sections that assess the patient's responses to the questions asked and also the practitioner's observations
  measure: incidence of postoperative delirium
  time frame: 2 days
  description: determine the incidence of postoperative delirium
  measure: length of hospital stay
  time frame: 2-21 days
  description: examine the relationship between delirium and hospital stay
  measure: postoperative pain assessment with Numeric Rating Scale (NRS)
  time frame: 2 days
  description: Numerical rating scales (NRSs) are the simplest and most commonly used scales.The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
  intervention type: Diagnostic Test
  intervention name: comparing DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium) tests to assess postoperative delirium
  description: determine the test that is more effective and practical in the assessment of POD
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zerrin SUNGUR, Prof Dr
  role: Study Chair
  affiliation: Istanbul University Istanbul Faculty of Medicine Department of Anesthesiology and Reanimation
  last name: Tuğçe DİNÇ DOĞAN, MD
  phone: 00905379412059
  email: tugce_dinc@hotmail.com
  last name: Ozlem TURHAN, MD
  phone: 00905055381923
  email: ozlemturhan6@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Turkey
  citation: Oh ST, Park JY. Postoperative delirium. Korean J Anesthesiol. 2019 Feb;72(1):4-12. doi: 10.4097/kja.d.18.00073.1. Epub 2018 Aug 24.
  PMID: 30139213
  citation: Janssen TL, Alberts AR, Hooft L, Mattace-Raso F, Mosk CA, van der Laan L. Prevention of postoperative delirium in elderly patients planned for elective surgery: systematic review and meta-analysis. Clin Interv Aging. 2019 Jun 19;14:1095-1117. doi: 10.2147/CIA.S201323. eCollection 2019.
  PMID: 31354253
  citation: American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5Ⓡ). 5th ed. Arlington, American Psychiatric Association Publishing. 2013, pp 596-601.
  citation: Palihnich K, Inouye SK, Marcantonio ER. The 3D CAM Training Manual for Research. 2014; Boston: Hospital Elder Life Program
  citation: Cinar MA,Ozmenler KN ,Ozsahin A ,Trzepacz Paula T. Dusunen Adam The Journal of Psychiatry and Neurological Sciences 2014; 3(27): 186-193 DOI: 10.5350/DAJPN2014270301
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University
  investigator full name: Ozlem Turhan
  investigator title: Principal Investigator
  mesh term: Delirium
  mesh term: Emergence Delirium
  sharing ipd: No