<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/NCT01720914</url>
  </required_header>
  <id_info>
    <org_study_id>IDEAS</org_study_id>
    <nct_id>NCT01720914</nct_id>
  </id_info>
  <brief_title>Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status</brief_title>
  <acronym>IDEAS</acronym>
  <official_title>Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status</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>
      In this prospective, multicenter observational study we assess the diagnostic validity of the&#xD;
      following standard screening instruments for delirium regarding sedation, analgesia and&#xD;
      ventilator status in critically ill patients:&#xD;
&#xD;
        -  Confusion Assessment Method for the ICU (CAM-ICU)&#xD;
&#xD;
        -  Intensive Care Delirium Screening Checklist (ICDSC)&#xD;
&#xD;
        -  Nursing-Delirium-Screening-Scale (Nu-DESC)&#xD;
&#xD;
      The definite delirium diagnosis (definite in terms of reference standard) is made according&#xD;
      to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition,&#xD;
      text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the&#xD;
      Gold Standard to diagnose delirium.&#xD;
&#xD;
      Primary research question: Does sedation, ventilator status and analgesia influence the&#xD;
      sensitivity of delirium screening tools (DST)?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2013</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;Confusion Assessment Method for the ICU (CAM-ICU)&quot; regarding sedation and ventilator status.</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>Used reference standard: DSM-IV TR criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity of the delirium-screening tool &quot;Intensive-Care Delirium Screening Checklist(ICDSC)&quot; regarding sedation and ventilator status.</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>Used reference standard: DSM-IV TR criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity of the delirium screening tool &quot;Nursing Delirium Screening Scale (Nu-DESC)&quot; regarding sedation and ventilator status.</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>Used reference standard: DSM-IV TR criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity of the &quot;Confusion Assessment Method for the ICU (CAM-ICU)&quot;, the &quot;Intensive Care Delirium Screening Checklist (ICDSC)&quot; and the &quot;Nursing Delirium Screening Scale&quot; regarding sedation and ventilator status.</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>Used reference standard: DSM-IV-TR criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales.</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>Calculation of positive and negative predictive values of the &quot;Confusion Assessment Method for the ICU (CAM-ICU)&quot;, the &quot;Intensive Care Delirium Screening Checklist (ICDSC)&quot; and the &quot;Nursing Delirium Screening Scale&quot; regarding sedation and ventilator status.&#xD;
Used reference standard: DSM-IV-TR criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of delirium</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Confusion Assessment Method for the ICU (CAM-ICU)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Subsyndromale Delirium (SSD)</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>According to Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesia</measure>
    <time_frame>Participants will be followed in the 7-days sample period:</time_frame>
    <description>According to Numeric rating scale visually enlarged and laminated (NRS-V), Behavioural pain scale (BPS) and Behavioural pain scale not intubated (BPS-NI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator status</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>Clinical observation of A) whether an airway is used B)whether a patient is ventilated with a positive pressure ventilation or a high flow ventilation for more than 6 hours per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Administered neuroleptics, cumulative</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Administered analgesics, cumulative</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Administered sedatives, cumulative</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of illness</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>according to Acute Physiology And Chronic Health score (APACHE 2), Simplified Acute Physiology Score (SAPS 2) and Sequential Organ Failure Assessment score (SOFA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotics/infections</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge mode</measure>
    <time_frame>Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of the &quot;Confusion Assessment Method for the ICU (CAM-ICU)&quot;, the &quot;Intensive Care Delirium Screening Checklist (ICDSC)&quot; and the &quot;Nursing Delirium Screening Scale&quot; regarding analgesia.</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>Used reference standard: DSM-IV-TR criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the &quot;Confusion Assessment Method for the ICU (CAM-ICU)&quot;, the &quot;Intensive Care Delirium Screening Checklist (ICDSC)&quot; and the &quot;Nursing Delirium Screening Scale&quot; regarding analgesia.</measure>
    <time_frame>Participants will be followed in the 7-days sample period</time_frame>
    <description>Used reference standard: DSM-IV-TR criteria.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Critically ill patient</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female adult critically ill patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critically ill patient&#xD;
&#xD;
          -  Patient age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurosurgical patients&#xD;
&#xD;
          -  Severe brain injury, intracerebral bleeding, stroke&#xD;
&#xD;
          -  Inability to communicate due to anacusia or severe hearing loss&#xD;
&#xD;
          -  Insufficient language comprehension&#xD;
&#xD;
          -  Patients &lt; 24 h total time of Intensive Care Unit stay&#xD;
&#xD;
          -  Deep sedation (RASS &lt; -3) for ≥ 7 days during study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro de Terapia Intensiva da Hospital Pro-Cardiaco</name>
      <address>
        <city>Botafogo</city>
        <state>Rio de Janeiro</state>
        <zip>RJ 22280-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>December 22, 2015</last_update_submitted>
  <last_update_submitted_qc>December 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2015</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>Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <!-- 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/NCT01720914
org study id: IDEAS
nct id: NCT01720914
lead sponsor: 
has dmc: No
In this prospective, multicenter observational study we assess the diagnostic validity of the
      following standard screening instruments for delirium regarding sedation, analgesia and
      ventilator status in critically ill patients:

        -  Confusion Assessment Method for the ICU (CAM-ICU)

        -  Intensive Care Delirium Screening Checklist (ICDSC)

        -  Nursing-Delirium-Screening-Scale (Nu-DESC)

      The definite delirium diagnosis (definite in terms of reference standard) is made according
      to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition,
      text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the
      Gold Standard to diagnose delirium.

      Primary research question: Does sedation, ventilator status and analgesia influence the
      sensitivity of delirium screening tools (DST)?
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of the delirium screening/diagnosing tool "Confusion Assessment Method for the ICU (CAM-ICU)" regarding sedation and ventilator status.
time frame: Participants will be followed in the 7-days sample period
description: Used reference standard: DSM-IV TR criteria
measure: Sensitivity of the delirium-screening tool "Intensive-Care Delirium Screening Checklist(ICDSC)" regarding sedation and ventilator status.
time frame: Participants will be followed in the 7-days sample period
description: Used reference standard: DSM-IV TR criteria.
measure: Sensitivity of the delirium screening tool "Nursing Delirium Screening Scale (Nu-DESC)" regarding sedation and ventilator status.
time frame: Participants will be followed in the 7-days sample period
description: Used reference standard: DSM-IV TR criteria
measure: Specificity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding sedation and ventilator status.
time frame: Participants will be followed in the 7-days sample period
description: Used reference standard: DSM-IV-TR criteria.
measure: Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales.
time frame: Participants will be followed in the 7-days sample period
description: Calculation of positive and negative predictive values of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding sedation and ventilator status.
Used reference standard: DSM-IV-TR criteria
measure: Incidence of delirium
time frame: Participants will be followed in the 7-days sample period
description: According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Confusion Assessment Method for the ICU (CAM-ICU)
measure: Incidence of Subsyndromale Delirium (SSD)
time frame: Participants will be followed in the 7-days sample period
description: According to Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC)
measure: Analgesia
time frame: Participants will be followed in the 7-days sample period:
description: According to Numeric rating scale visually enlarged and laminated (NRS-V), Behavioural pain scale (BPS) and Behavioural pain scale not intubated (BPS-NI)
measure: Ventilator status
time frame: Participants will be followed in the 7-days sample period
description: Clinical observation of A) whether an airway is used B)whether a patient is ventilated with a positive pressure ventilation or a high flow ventilation for more than 6 hours per day.
measure: Administered neuroleptics, cumulative
time frame: Participants will be followed in the 7-days sample period
measure: Administered analgesics, cumulative
time frame: Participants will be followed in the 7-days sample period
measure: Administered sedatives, cumulative
time frame: Participants will be followed in the 7-days sample period
measure: Severity of illness
time frame: Participants will be followed in the 7-days sample period
description: according to Acute Physiology And Chronic Health score (APACHE 2), Simplified Acute Physiology Score (SAPS 2) and Sequential Organ Failure Assessment score (SOFA)
measure: Antibiotics/infections
time frame: Participants will be followed in the 7-days sample period
measure: ICU length of stay
time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: Duration of mechanical ventilation
time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: Discharge mode
time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: 28-day mortality
time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: Specificity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding analgesia.
time frame: Participants will be followed in the 7-days sample period
description: Used reference standard: DSM-IV-TR criteria.
measure: Sensitivity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding analgesia.
time frame: Participants will be followed in the 7-days sample period
description: Used reference standard: DSM-IV-TR criteria.
arm group label: Critically ill patient
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Brazil
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
mesh term: Delirium