<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/NCT04460716</url>
  </required_header>
  <id_info>
    <org_study_id>PODMAS</org_study_id>
    <nct_id>NCT04460716</nct_id>
  </id_info>
  <brief_title>Predictors for Postoperative Delirium After Major Noncardiac Surgery in Adults</brief_title>
  <acronym>PODMAS</acronym>
  <official_title>Predictors for Postoperative Delirium After Major Noncardiac Surgery in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      This research project is an observational cohort study by retrospective chart review of&#xD;
      patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland,&#xD;
      in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general&#xD;
      surgical population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium&#xD;
      as a &quot;disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift&#xD;
      attention) and awareness (reduced orientation to the environment)&quot;. In addition, a&#xD;
      &quot;disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial&#xD;
      ability, or perception)&quot; occurs. The deficits cannot be explained by other neurocognitive&#xD;
      disorders.&#xD;
&#xD;
      Delirium develops within hours to a few days and can fluctuate in severity during the day.&#xD;
      Acute delirium lasts a few hours or days, whereas persistent delirium lasts for weeks or&#xD;
      months. In a hospital setting, delirium hardly ever lasts longer than a week but some&#xD;
      symptoms can persist for months after the patient was discharged.&#xD;
&#xD;
      According to the International Statistical Classification of Diseases and Related Health&#xD;
      Problems, 10th rev. (ICD-10), delirium is a pathologic brain disorder, which consists of a&#xD;
      disturbance in consciousness, attention, perception, memory, psychomotor functions, emotional&#xD;
      stability, and circadian rhythm. The severity can range from mild to very severe POD occurs&#xD;
      in connection with a surgical procedure within the first four days after an intervention.&#xD;
      10-70% of all surgical patients above the age of 65 years are affected.&#xD;
&#xD;
      Delirium is not only a burden to the patient and their family by increasing functional and&#xD;
      cognitive damages, and increasing mortality, it has a high impact on the economy, as well. A&#xD;
      patient with delirium has a longer length of hospital stay, more complications, and often&#xD;
      requires long-term care after being discharged from the hospital. All these aspects show the&#xD;
      need for prevention of delirium.&#xD;
&#xD;
      There are various preoperative risk factors that influence the development of POD. Advanced&#xD;
      age, preexisting cognitive impairment, depression and other psychopathologic symptoms, intake&#xD;
      of psychotropic substances, sensory impairment like decrease in visual or auditory&#xD;
      perception, impairment in daily life activities, dehydration, malnutrition, metabolic&#xD;
      dysfunctions, urinary catheters, severe diseases and different comorbidities such as chronic&#xD;
      cardiac insufficiency, atrial fibrillation, or previous history of stroke or infections favor&#xD;
      the development of delirium.&#xD;
&#xD;
      The incidence of POD after major noncardiac surgery and the burden to patients and healthcare&#xD;
      systems in general is high.&#xD;
&#xD;
      This research project is an observational cohort study by retrospective chart review of&#xD;
      patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland,&#xD;
      in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general&#xD;
      surgical population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of postoperative delirium</measure>
    <time_frame>Daily assessment of postoperative delirium from postoperative day 1 up to postoperative day 30 or hospital discharge, whichever comes first</time_frame>
    <description>Incidence of postoperative delirium assessed by a validated delirium measurement tool (CAM, 3D-CAM, CAM-ICU, ICDSC, MDAS, GAR, DOSS, Nu-DESC, DRS-R-98, and/or patient chart review)</description>
  </primary_outcome>
  <enrollment type="Actual">5000</enrollment>
  <condition>Postoperative Delirium</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Major noncardiac surgery</intervention_name>
    <description>Vascular, thoracic, visceral, orthopedic, gynecologic, urologic, ENT, maxillo-facial, plastic and reconstructive surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who underwent major noncardiac surgery at the University Hospital Basel during&#xD;
        the years 2011-2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who underwent major noncardiac surgery at the University Hospital Basel&#xD;
             during the years 2011-2015.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that died during the operation or one day after surgery.&#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>Nicolai Goettel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Basel, Switzerland</investigator_affiliation>
    <investigator_full_name>Nicolai Goettel</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <!-- 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/NCT04460716
org study id: PODMAS
nct id: NCT04460716
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research project is an observational cohort study by retrospective chart review of
      patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland,
      in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general
      surgical population.
The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium
      as a "disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift
      attention) and awareness (reduced orientation to the environment)". In addition, a
      "disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial
      ability, or perception)" occurs. The deficits cannot be explained by other neurocognitive
      disorders.

      Delirium develops within hours to a few days and can fluctuate in severity during the day.
      Acute delirium lasts a few hours or days, whereas persistent delirium lasts for weeks or
      months. In a hospital setting, delirium hardly ever lasts longer than a week but some
      symptoms can persist for months after the patient was discharged.

      According to the International Statistical Classification of Diseases and Related Health
      Problems, 10th rev. (ICD-10), delirium is a pathologic brain disorder, which consists of a
      disturbance in consciousness, attention, perception, memory, psychomotor functions, emotional
      stability, and circadian rhythm. The severity can range from mild to very severe POD occurs
      in connection with a surgical procedure within the first four days after an intervention.
      10-70% of all surgical patients above the age of 65 years are affected.

      Delirium is not only a burden to the patient and their family by increasing functional and
      cognitive damages, and increasing mortality, it has a high impact on the economy, as well. A
      patient with delirium has a longer length of hospital stay, more complications, and often
      requires long-term care after being discharged from the hospital. All these aspects show the
      need for prevention of delirium.

      There are various preoperative risk factors that influence the development of POD. Advanced
      age, preexisting cognitive impairment, depression and other psychopathologic symptoms, intake
      of psychotropic substances, sensory impairment like decrease in visual or auditory
      perception, impairment in daily life activities, dehydration, malnutrition, metabolic
      dysfunctions, urinary catheters, severe diseases and different comorbidities such as chronic
      cardiac insufficiency, atrial fibrillation, or previous history of stroke or infections favor
      the development of delirium.

      The incidence of POD after major noncardiac surgery and the burden to patients and healthcare
      systems in general is high.

      This research project is an observational cohort study by retrospective chart review of
      patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland,
      in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general
      surgical population.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of postoperative delirium
time frame: Daily assessment of postoperative delirium from postoperative day 1 up to postoperative day 30 or hospital discharge, whichever comes first
description: Incidence of postoperative delirium assessed by a validated delirium measurement tool (CAM, 3D-CAM, CAM-ICU, ICDSC, MDAS, GAR, DOSS, Nu-DESC, DRS-R-98, and/or patient chart review)
intervention type: Procedure
intervention name: Major noncardiac surgery
description: Vascular, thoracic, visceral, orthopedic, gynecologic, urologic, ENT, maxillo-facial, plastic and reconstructive surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolai Goettel, MD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Basel, Switzerland
investigator full name: Nicolai Goettel
investigator title: Principal Investigator
mesh term: Delirium
mesh term: Emergence Delirium