<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/NCT04467307</url>
  </required_header>
  <id_info>
    <org_study_id>2020/02-02</org_study_id>
    <nct_id>NCT04467307</nct_id>
  </id_info>
  <brief_title>Comparison of Patients With and Without Foreign Body Aspiration After Bronchoscopy.</brief_title>
  <official_title>Comparison of Symptoms and Findings and Short-term Results After Bronchoscopy in Patients With and Without the Foreign Body in Children Under 5 Years Old Who Underwent Bronchoscopy With Suspicion of Foreign Body Aspiration. A Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam 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>
      To compare patients under 5 years of age with foreign body aspiration and without foreign&#xD;
      body aspiration with radiological and blood gas results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Foreign body aspiration in children is a serious cause of mortality and morbidity. It is a&#xD;
      preventable and treatable disease. Difficulties in diagnosis arise in non-radiopaque foreign&#xD;
      body aspirations. Recently, when there is a suspicious history, bronchoscopy is recommended.&#xD;
      Bronchoscopy is used to both diagnose and treat foreign body aspiration. Bronchoscopy seems&#xD;
      to continue to be performed in suspicious cases until a method to establish a definitive&#xD;
      diagnosis of foreign body aspirations before the operation is invented. In our study, to&#xD;
      compare patients under 5 years of age with foreign body aspiration and without foreign body&#xD;
      aspiration with radiological and blood gas results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Foreign body aspiration</measure>
    <time_frame>1 week</time_frame>
    <description>The presence of a foreign body in the airway by bronchoscopy, radiological findings, blood gas</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Foreign Body Aspiration, Blood Gas, Bronchoscopy</condition>
  <arm_group>
    <arm_group_label>Foreign body aspiration.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing bronchoscopy with suspicion of foreign body aspiration. There is a foreign body in the bronchoscopy performed on these patients and it is the treated group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group with no foreign body aspiration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing bronchoscopy with suspicion of foreign body aspiration, but there is no foreign body in bronchoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rigit bronchoscopy</intervention_name>
    <description>After general anesthesia, the airway is checked with a rigid bronchoscope suitable for the age. If there is a foreign body, it is removed by forceps.</description>
    <arm_group_label>Foreign body aspiration.</arm_group_label>
    <arm_group_label>Group with no foreign body aspiration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Suspected foreign body aspiration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        infection, trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ahmet gokhan güler</last_name>
    <phone>+905057702633</phone>
    <email>drgokhanguler@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mustafa sabih kaya</last_name>
    <phone>+905316828311</phone>
    <email>sabihkaya@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kahramanmaras Sutcu Imam University</name>
      <address>
        <city>Kahramanmaras</city>
        <state>Onikisubat</state>
        <zip>46050</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ahmet gökhan güler</last_name>
      <phone>+905057702633</phone>
      <email>drgokhanguler@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
    <investigator_full_name>Ahmet Gökhan Güler</investigator_full_name>
    <investigator_title>Department of pediatric surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Foreign Bodies</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/NCT04467307
org study id: 2020/02-02
nct id: NCT04467307
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare patients under 5 years of age with foreign body aspiration and without foreign
      body aspiration with radiological and blood gas results.
Foreign body aspiration in children is a serious cause of mortality and morbidity. It is a
      preventable and treatable disease. Difficulties in diagnosis arise in non-radiopaque foreign
      body aspirations. Recently, when there is a suspicious history, bronchoscopy is recommended.
      Bronchoscopy is used to both diagnose and treat foreign body aspiration. Bronchoscopy seems
      to continue to be performed in suspicious cases until a method to establish a definitive
      diagnosis of foreign body aspirations before the operation is invented. In our study, to
      compare patients under 5 years of age with foreign body aspiration and without foreign body
      aspiration with radiological and blood gas results.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Foreign body aspiration
time frame: 1 week
description: The presence of a foreign body in the airway by bronchoscopy, radiological findings, blood gas
arm group label: Foreign body aspiration.
arm group type: Active Comparator
description: Patients undergoing bronchoscopy with suspicion of foreign body aspiration. There is a foreign body in the bronchoscopy performed on these patients and it is the treated group.
arm group label: Group with no foreign body aspiration
arm group type: Active Comparator
description: Patients undergoing bronchoscopy with suspicion of foreign body aspiration, but there is no foreign body in bronchoscopy.
intervention type: Device
intervention name: Rigit bronchoscopy
description: After general anesthesia, the airway is checked with a rigid bronchoscope suitable for the age. If there is a foreign body, it is removed by forceps.
arm group label: Foreign body aspiration.
arm group label: Group with no foreign body aspiration
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Years
healthy volunteers: No
last name: ahmet gokhan güler
phone: +905057702633
email: drgokhanguler@gmail.com
last name: mustafa sabih kaya
phone: +905316828311
email: sabihkaya@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Ahmet Gökhan Güler
investigator title: Department of pediatric surgery
mesh term: Foreign Bodies