<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/NCT04447638</url>
  </required_header>
  <id_info>
    <org_study_id>TT17</org_study_id>
    <nct_id>NCT04447638</nct_id>
  </id_info>
  <brief_title>Percutaneous Tracheostomy With COVID-19</brief_title>
  <official_title>Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Çanakkale Onsekiz Mart University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Çanakkale Onsekiz Mart University</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>
      Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and&#xD;
      mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is&#xD;
      performed in order to reduce the complications that may develop due to prolonged endotracheal&#xD;
      intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Different methods are needed for situations in which the potential for producing aerosols is&#xD;
      high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share&#xD;
      our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients.&#xD;
      Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the&#xD;
      pandemic intensive care unit were evaluated retrospectively.The study is designed as a&#xD;
      clinical trial study. This study was performed in faculty of medicine hospital's intensive&#xD;
      care unit which is located in Canakkale province Turkey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box</measure>
    <time_frame>During the procedure</time_frame>
    <description>Complications</description>
  </primary_outcome>
  <enrollment type="Actual">24</enrollment>
  <condition>Tracheostomy</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tracheostomy with aerosol box in COVID-19 positive patients</intervention_name>
    <description>Patients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Percutaneous tracheostomy performed with aerosol box in COVID-19 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  who underwent percutaneous tracheostomy with COVID-19(+)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not give informed consent or do not want to participate in the study&#xD;
&#xD;
          -  Coagulopathy, thrombocytopenia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Canakkale Onsekiz Mart University</name>
      <address>
        <city>Canakkale</city>
        <zip>17020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Çanakkale Onsekiz Mart University</investigator_affiliation>
    <investigator_full_name>Mesut ERBAS</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Reanimation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04447638
org study id: TT17
nct id: NCT04447638
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and
      mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is
      performed in order to reduce the complications that may develop due to prolonged endotracheal
      intubation.
Different methods are needed for situations in which the potential for producing aerosols is
      high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share
      our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients.
      Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the
      pandemic intensive care unit were evaluated retrospectively.The study is designed as a
      clinical trial study. This study was performed in faculty of medicine hospital's intensive
      care unit which is located in Canakkale province Turkey.
observational model: Case-Only
time perspective: Retrospective
measure: Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box
time frame: During the procedure
description: Complications
intervention type: Procedure
intervention name: Tracheostomy with aerosol box in COVID-19 positive patients
description: Patients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Çanakkale Onsekiz Mart University
investigator full name: Mesut ERBAS
investigator title: Associate Professor
sharing ipd: Undecided