<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/NCT02216929</url>
  </required_header>
  <id_info>
    <org_study_id>GK2</org_study_id>
    <nct_id>NCT02216929</nct_id>
  </id_info>
  <brief_title>Assessment of the Patients of Emergency Consultation</brief_title>
  <acronym>ICU</acronym>
  <official_title>The Demographics, Mortality and Clinical Diagnosis of the Patients Who Were Evaluated, Intubated and Interned to ICU by the Anesthesiology in 2010-2011</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gulsah Karaoren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The demographic data, mortality rates and clinical diagnoses of the patients who were&#xD;
      evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent&#xD;
      consultation call from the emergency department in 2010-2011.&#xD;
&#xD;
      Primary outcome: an examination of demographic data, predicted mortality rates and the&#xD;
      clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio&#xD;
      Inclusion criteria: patients throughout the hole hospital whom was intubated by the&#xD;
      anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who&#xD;
      refused treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The demographic data and findings completed in the Emergency Department were obtained from&#xD;
      the patient cards and information related to existing diseases was obtained from the patient&#xD;
      records for the cases included in the study.&#xD;
&#xD;
      Predicted mortality values were calculated for each patient with Apache II and SAPS II values&#xD;
      using the worst or most critical physiological and laboratory parameters in the first 24&#xD;
      hours in the Emergency Department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">March 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The evaluation of the terminal phase cancer ratio</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the ratio of patients with terminal phase cancer who were intubated and interned to the intensive care unit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic data of urgent anaesthesiology consultations required intubation</measure>
    <time_frame>12 months</time_frame>
    <description>The evaluation of the demographics, clinical diagnosis and the calculated values of APACHE II, SAPS II and predicted mortality of the patients who were intubated and interned to the ICU by anesthesiology department due to an urgent consultation call.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The ratio of patients required cardiopulmonary resuscitation</measure>
    <time_frame>12 months</time_frame>
    <description>The rate of CPR, the APACHE II and SAPS II expanded values of the patients required CPR .</description>
  </other_outcome>
  <enrollment type="Actual">287</enrollment>
  <condition>Demographics of Intubated Patients Due to an Urgent Call</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study aimed to retrospectively evaluate patients throughout the whole hospital who&#xD;
        were intubated and interned to the ICU by anaesthesiology team due to an urgent&#xD;
        consultation call in our hospital during 2010-2011.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients throughout the hole hospital whom was intubated by the anaesthesiology team&#xD;
             due to an urgent consultation call&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  patients who refused treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huseyin Oz, Prof Dr</last_name>
    <role>Study Director</role>
    <affiliation>Medipol University Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University Faculty of Cerrahpasa Medicine</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kim AS, Youn CH, Ko HJ, Kim HM. The survival time of terminal cancer patients: prediction based on clinical parameters and simple prognostic scores. J Palliat Care. 2014 Spring;30(1):24-31.</citation>
    <PMID>24826440</PMID>
  </reference>
  <reference>
    <citation>Uy J, White DB, Mohan D, Arnold RM, Barnato AE. Physicians' decision-making roles for an acutely unstable critically and terminally ill patient. Crit Care Med. 2013 Jun;41(6):1511-7. doi: 10.1097/CCM.0b013e318287f0dd.</citation>
    <PMID>23552510</PMID>
  </reference>
  <results_reference>
    <citation>Lissauer ME, Naranjo LS, Kirchoffner J, Scalea TM, Johnson SB. Patient characteristics associated with end-of-life decision making in critically ill surgical patients. J Am Coll Surg. 2011 Dec;213(6):766-70. doi: 10.1016/j.jamcollsurg.2011.09.003.</citation>
    <PMID>22107920</PMID>
  </results_reference>
  <verification_date>January 2011</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Gulsah Karaoren</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>intubation</keyword>
  <keyword>intensive care</keyword>
  <keyword>withholding treatment</keyword>
  <keyword>cancer</keyword>
  <keyword>terminal care</keyword>
  <keyword>APACHE</keyword>
  <!-- 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/NCT02216929
org study id: GK2
nct id: NCT02216929
lead sponsor: 
has dmc: Yes
The demographic data, mortality rates and clinical diagnoses of the patients who were
      evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent
      consultation call from the emergency department in 2010-2011.

      Primary outcome: an examination of demographic data, predicted mortality rates and the
      clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio
      Inclusion criteria: patients throughout the hole hospital whom was intubated by the
      anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who
      refused treatment
The demographic data and findings completed in the Emergency Department were obtained from
      the patient cards and information related to existing diseases was obtained from the patient
      records for the cases included in the study.

      Predicted mortality values were calculated for each patient with Apache II and SAPS II values
      using the worst or most critical physiological and laboratory parameters in the first 24
      hours in the Emergency Department.
time perspective: Retrospective
measure: The evaluation of the terminal phase cancer ratio
time frame: 12 months
description: To determine the ratio of patients with terminal phase cancer who were intubated and interned to the intensive care unit.
measure: Demographic data of urgent anaesthesiology consultations required intubation
time frame: 12 months
description: The evaluation of the demographics, clinical diagnosis and the calculated values of APACHE II, SAPS II and predicted mortality of the patients who were intubated and interned to the ICU by anesthesiology department due to an urgent consultation call.
measure: The ratio of patients required cardiopulmonary resuscitation
time frame: 12 months
description: The rate of CPR, the APACHE II and SAPS II expanded values of the patients required CPR .
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Huseyin Oz, Prof Dr
role: Study Director
affiliation: Medipol University Faculty of Medicine
facility: 
country: Turkey
citation: Kim AS, Youn CH, Ko HJ, Kim HM. The survival time of terminal cancer patients: prediction based on clinical parameters and simple prognostic scores. J Palliat Care. 2014 Spring;30(1):24-31.
PMID: 24826440
citation: Uy J, White DB, Mohan D, Arnold RM, Barnato AE. Physicians' decision-making roles for an acutely unstable critically and terminally ill patient. Crit Care Med. 2013 Jun;41(6):1511-7. doi: 10.1097/CCM.0b013e318287f0dd.
PMID: 23552510
citation: Lissauer ME, Naranjo LS, Kirchoffner J, Scalea TM, Johnson SB. Patient characteristics associated with end-of-life decision making in critically ill surgical patients. J Am Coll Surg. 2011 Dec;213(6):766-70. doi: 10.1016/j.jamcollsurg.2011.09.003.
PMID: 22107920
responsible party type: Sponsor-Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Gulsah Karaoren
investigator title: Doctor