<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/NCT02203435</url>
  </required_header>
  <id_info>
    <org_study_id>GK1</org_study_id>
    <nct_id>NCT02203435</nct_id>
  </id_info>
  <brief_title>The Patient Characteristics and Mortality of Code Blue Calls</brief_title>
  <official_title>The Characteristics of the Blue-code Calls; Five Years Survey.</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>
      This study aimed to retrospectively examine patients evaluated by the Code Blue team on a&#xD;
      Code Blue call in our hospital between 2009 and 2013.&#xD;
&#xD;
      Primary outcome: an examination of the survival rates and demographic data of the patients&#xD;
      evaluated as an emergency by a Code Blue call in the period 2009-2013.Secondary outcome: to&#xD;
      determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the&#xD;
      relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients&#xD;
      throughout the whole hospital for whom a Code Blue form was completed and who were evaluated&#xD;
      by the Code Blue team on a Code Blue call.&#xD;
&#xD;
      Exclusion criteria: patients who refused treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective examination was made of the Code Blue notification forms which were completed&#xD;
      by the anaesthesiologist as Code Blue team leader of the hospital. The age of the patient,&#xD;
      gender, diagnosis, the department where admitted, time of Blue Code call, reason for Blue&#xD;
      Code call, whether or not the Blue code call was appropriate, whether or not cardiopulmonary&#xD;
      resuscitation was administered, if administered, the duration of cardiopulmonary&#xD;
      resuscitation, whether or not the patient was postoperative, whether or not the patient had&#xD;
      been discharged from the intensive care unit and if so, how many days had passed, the APACHE&#xD;
      II score of the patient and expected mortality, were recorded by calculation of the data on&#xD;
      thhe Code Blue notification form and in the hospital automated system. Patients were excluded&#xD;
      from the study if they had refused treatment or if there was no record of the parameters&#xD;
      necessary to calculate the APACHE II score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>mortality of blue-codes</measure>
    <time_frame>5 years</time_frame>
    <description>an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2009-2013.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the demographics of blue code admissions</measure>
    <time_frame>5 years</time_frame>
    <description>to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>the rate of successful cardiopulmonary resuscitation</measure>
    <time_frame>5 years</time_frame>
    <description>the rate of CPR, the apache and saps II expanded values and indication of ICU stay will be calculated</description>
  </other_outcome>
  <enrollment type="Actual">1050</enrollment>
  <condition>Demographics of the Patients Evaluated by Code Blue Call</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study aimed to retrospectively examine patients evaluated by the Code Blue team on a&#xD;
        Code Blue call in our hospital between 2009 and 2013.Retrospective examination was made of&#xD;
        the Code Blue notification forms which were completed by the anaesthesiologist as Code Blue&#xD;
        team leader of the hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients throughout the whole hospital for whom a Code Blue form was completed and who were&#xD;
        evaluated by the Code Blue team on a Code Blue call.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who refused treatment&#xD;
&#xD;
        -&#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>Nurten Bakan, assoc prof</last_name>
    <role>Study Director</role>
    <affiliation>Istanbul Umraniye Education and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Umraniye Education and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34760</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Grimaldi D, Dumas F, Perier MC, Charpentier J, Varenne O, Zuber B, Vivien B, Pene F, Mira JP, Empana JP, Cariou A. Short- and long-term outcome in elderly patients after out-of-hospital cardiac arrest: a cohort study. Crit Care Med. 2014 Nov;42(11):2350-7. doi: 10.1097/CCM.0000000000000512.</citation>
    <PMID>25054671</PMID>
  </reference>
  <results_reference>
    <citation>Fecho K, Jackson F, Smith F, Overdyk FJ. In-hospital resuscitation: opioids and other factors influencing survival. Ther Clin Risk Manag. 2009;5:961-8. doi: 10.2147/tcrm.s8121. Epub 2009 Dec 29.</citation>
    <PMID>20057895</PMID>
  </results_reference>
  <results_reference>
    <citation>Yang J, Howell MD. Commentary: Is the glass half empty? Code blue training in the modern era. Acad Med. 2011 Jun;86(6):680-3. doi: 10.1097/ACM.0b013e318217e969.</citation>
    <PMID>21613890</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 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>code blue</keyword>
  <keyword>Cardiopulmonary Resuscitation</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/NCT02203435
org study id: GK1
nct id: NCT02203435
lead sponsor: 
has dmc: Yes
This study aimed to retrospectively examine patients evaluated by the Code Blue team on a
      Code Blue call in our hospital between 2009 and 2013.

      Primary outcome: an examination of the survival rates and demographic data of the patients
      evaluated as an emergency by a Code Blue call in the period 2009-2013.Secondary outcome: to
      determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the
      relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients
      throughout the whole hospital for whom a Code Blue form was completed and who were evaluated
      by the Code Blue team on a Code Blue call.

      Exclusion criteria: patients who refused treatment
Retrospective examination was made of the Code Blue notification forms which were completed
      by the anaesthesiologist as Code Blue team leader of the hospital. The age of the patient,
      gender, diagnosis, the department where admitted, time of Blue Code call, reason for Blue
      Code call, whether or not the Blue code call was appropriate, whether or not cardiopulmonary
      resuscitation was administered, if administered, the duration of cardiopulmonary
      resuscitation, whether or not the patient was postoperative, whether or not the patient had
      been discharged from the intensive care unit and if so, how many days had passed, the APACHE
      II score of the patient and expected mortality, were recorded by calculation of the data on
      thhe Code Blue notification form and in the hospital automated system. Patients were excluded
      from the study if they had refused treatment or if there was no record of the parameters
      necessary to calculate the APACHE II score.
time perspective: Retrospective
measure: mortality of blue-codes
time frame: 5 years
description: an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2009-2013.
measure: the demographics of blue code admissions
time frame: 5 years
description: to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.
measure: the rate of successful cardiopulmonary resuscitation
time frame: 5 years
description: the rate of CPR, the apache and saps II expanded values and indication of ICU stay will be calculated
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nurten Bakan, assoc prof
role: Study Director
affiliation: Istanbul Umraniye Education and Research Hospital
facility: 
country: Turkey
citation: Grimaldi D, Dumas F, Perier MC, Charpentier J, Varenne O, Zuber B, Vivien B, Pene F, Mira JP, Empana JP, Cariou A. Short- and long-term outcome in elderly patients after out-of-hospital cardiac arrest: a cohort study. Crit Care Med. 2014 Nov;42(11):2350-7. doi: 10.1097/CCM.0000000000000512.
PMID: 25054671
citation: Fecho K, Jackson F, Smith F, Overdyk FJ. In-hospital resuscitation: opioids and other factors influencing survival. Ther Clin Risk Manag. 2009;5:961-8. doi: 10.2147/tcrm.s8121. Epub 2009 Dec 29.
PMID: 20057895
citation: Yang J, Howell MD. Commentary: Is the glass half empty? Code blue training in the modern era. Acad Med. 2011 Jun;86(6):680-3. doi: 10.1097/ACM.0b013e318217e969.
PMID: 21613890
responsible party type: Sponsor-Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Gulsah Karaoren
investigator title: doctor