<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/NCT02227225</url>
  </required_header>
  <id_info>
    <org_study_id>C2014/748</org_study_id>
    <nct_id>NCT02227225</nct_id>
  </id_info>
  <brief_title>Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly</brief_title>
  <official_title>Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly Undergoing Non-cardiac Surgery: An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Singapore General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative delirium has been found to be associated with increased risk of future&#xD;
      neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has&#xD;
      been found to be associated with an increased risk of postoperative complication including&#xD;
      delirium in the elderly.The purpose of this study is determine the factors affecting the&#xD;
      incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the&#xD;
      Singapore population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">August 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative delirium</measure>
    <time_frame>upto 3 postoperative days</time_frame>
    <description>Confusion assessment method (CAM) will be used to asses delirium</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Postoperative Delirium</condition>
  <arm_group>
    <arm_group_label>Postoperative Delirium</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Postoperative inpatients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly (&gt; 65 years) frail patients undergoing non cardiac surgery under anaesthesia&#xD;
             lasting for &gt;60 minutes&#xD;
&#xD;
          -  Patient willing and able to complete the requirements of this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  disabling neuropsychiatric or neurological disorders(including severe dementia,&#xD;
             Alzheimer's disease, schizophrenia, severe depression)&#xD;
&#xD;
          -  patients suffering from delirium at selection;&#xD;
&#xD;
          -  patients who cannot complete the preoperative mental tests (CAM and/or Mini-Mental&#xD;
             State Examination (MMSE)) of this clinical trial;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shariq A Khan, FRCA</last_name>
    <email>Shariq.ali.khan@sgh.com.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shariq A Khan, FRCA</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>January 13, 2015</last_update_submitted>
  <last_update_submitted_qc>January 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Singapore General Hospital</investigator_affiliation>
    <investigator_full_name>Shariq Ali Khan</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>Postoperative 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>
  <!-- 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/NCT02227225
org study id: C2014/748
nct id: NCT02227225
lead sponsor: 
has dmc: No
Postoperative delirium has been found to be associated with increased risk of future
      neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has
      been found to be associated with an increased risk of postoperative complication including
      delirium in the elderly.The purpose of this study is determine the factors affecting the
      incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the
      Singapore population.
observational model: Cohort
time perspective: Prospective
measure: postoperative delirium
time frame: upto 3 postoperative days
description: Confusion assessment method (CAM) will be used to asses delirium
arm group label: Postoperative Delirium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Shariq A Khan, FRCA
email: Shariq.ali.khan@sgh.com.sg
facility: 
status: Recruiting
contact: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Singapore General Hospital
investigator full name: Shariq Ali Khan
investigator title: Consultant
mesh term: Delirium
mesh term: Emergence Delirium