<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/NCT04480060</url>
  </required_header>
  <id_info>
    <org_study_id>KSSEAH--EDCC</org_study_id>
    <nct_id>NCT04480060</nct_id>
  </id_info>
  <brief_title>Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic</brief_title>
  <official_title>Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic: Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</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>
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to&#xD;
      many countries of the world. Emergency departments also carried out an important part of the&#xD;
      fight against pandemics in our country/Turkey. The emergency department including an&#xD;
      intensive care unit is very few in this country/Turkey and the only hospital, which has an&#xD;
      Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Therefore, this&#xD;
      retrospective study aimed to provide useful information about how an effective EICU should&#xD;
      be, especially how to use them during pandemic periods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to&#xD;
      many countries of the world. Emergency departments also carried out an important part of the&#xD;
      fight against pandemics in our country/Turkey. The emergency department including an&#xD;
      intensive care unit is very few in this country/Turkey and the only hospital, which has an&#xD;
      Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Throughout the&#xD;
      pandemic, many patients, including COVID-19 patients, were successfully followed up and&#xD;
      discharged from EICU. With this study, the investigators expect to show the role of EICU&#xD;
      during the pandemic. In addition, it will be seen that whether the patients, who are waiting&#xD;
      for hospitalization or waiting for referral, are admitted to EICU faster and their treatments&#xD;
      will be started promptly. Therefore, this retrospective study aimed to provide useful&#xD;
      information about how an effective EICU should be, especially how to use them during pandemic&#xD;
      periods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Actual">July 14, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Mortality of the COVID-19 patients</measure>
    <time_frame>3 months</time_frame>
    <description>Mortality of the COVID-19 patients who followed up by emergency department ICU</description>
  </primary_outcome>
  <enrollment type="Actual">100000</enrollment>
  <condition>Covid19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>COVID-19 diagnostic PCR</intervention_name>
    <description>Nasopharyngeal swab samples will be analyzed by PCR for COVID-19 DNA existence.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who followed up in emergency department ICU's of study centers with the&#xD;
        diagnosis of COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who followed up in emergency department ICU with the diagnosis of&#xD;
             COVID-19&#xD;
&#xD;
          -  Accepted to participate with an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18 or more than 50 years&#xD;
&#xD;
          -  declined to participate&#xD;
&#xD;
          -  deaths caused by other than COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seda Yilmaz Semerci</name>
      <address>
        <city>Istanbul</city>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ramazan Guven</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04480060
org study id: KSSEAH--EDCC
nct id: NCT04480060
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. Emergency departments also carried out an important part of the
      fight against pandemics in our country/Turkey. The emergency department including an
      intensive care unit is very few in this country/Turkey and the only hospital, which has an
      Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Therefore, this
      retrospective study aimed to provide useful information about how an effective EICU should
      be, especially how to use them during pandemic periods.
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. Emergency departments also carried out an important part of the
      fight against pandemics in our country/Turkey. The emergency department including an
      intensive care unit is very few in this country/Turkey and the only hospital, which has an
      Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Throughout the
      pandemic, many patients, including COVID-19 patients, were successfully followed up and
      discharged from EICU. With this study, the investigators expect to show the role of EICU
      during the pandemic. In addition, it will be seen that whether the patients, who are waiting
      for hospitalization or waiting for referral, are admitted to EICU faster and their treatments
      will be started promptly. Therefore, this retrospective study aimed to provide useful
      information about how an effective EICU should be, especially how to use them during pandemic
      periods.
observational model: Cohort
time perspective: Retrospective
measure: Mortality of the COVID-19 patients
time frame: 3 months
description: Mortality of the COVID-19 patients who followed up by emergency department ICU
intervention type: Diagnostic Test
intervention name: COVID-19 diagnostic PCR
description: Nasopharyngeal swab samples will be analyzed by PCR for COVID-19 DNA existence.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Ramazan Guven
investigator title: Professor
mesh term: COVID-19
mesh term: Emergencies
sharing ipd: No