xml: <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/NCT06000995</url>
    </required_header>
    <id_info>
      <org_study_id>B.30.2.ODM.0.20.08/340</org_study_id>
      <nct_id>NCT06000995</nct_id>
    </id_info>
    <brief_title>Determination of Fiberoptic Bronchoscopy Sedation Protocols in Turkey</brief_title>
    <official_title>Determination of Fiberoptic Bronchoscopy Sedation Protocols; Survey Study on Sedation Attitudes and Behaviors of Chest Diseases Specialists in Turkey</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samsun University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samsun University</source>
    <brief_summary>
      <textblock>
        Fiberoptic bronchoscopy (FOB), which is difficult to tolerate while awake, is recommended to&#xD;
        be performed by the patient under sedation. The aim of this study is to determine the&#xD;
        attitudes and behaviors of chest diseases specialists who do FOB in Turkey about sedation&#xD;
        with a 30-question online questionnaire.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Fiberoptic bronchoscopy is the imaging of the tracheobronchial tree for diagnosis and&#xD;
        treatment in lung diseases. The operation performed through the airway is difficult for the&#xD;
        patient to tolerate. Therefore, it is recommended to perform the procedure under sedation.&#xD;
        With this survey study, it was aimed to determine the sedation protocols preferred by&#xD;
        pulmonologists who perform active fiberoptic bronchoscopy throughout Turkey during the&#xD;
        procedure.&#xD;
  &#xD;
        Thirty questions were determined for the questionnaire to be used as a data collection method&#xD;
        by the researchers. The questions generally consist of three parts; In the first part, there&#xD;
        are 8 questions containing the personal information of the doctors (age, gender, title,&#xD;
        institution, etc.). In the second part, 13 questions were included in order to make a general&#xD;
        assessment such as the sedative agents used by the doctors before and during the bronchoscopy&#xD;
        procedure, and the satisfaction with the sedative method used. In the third part, 9 questions&#xD;
        were given to determine the preferred follow-up methods during the procedure. The questions&#xD;
        are designed to be presented to participants over the network using google forms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 16, 2022</start_date>
    <completion_date type="Actual">July 31, 2022</completion_date>
    <primary_completion_date type="Actual">July 30, 2022</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>FOB related survey questions</measure>
      <time_frame>15 minutes</time_frame>
      <description>The pulmonologists' responses to 30 questionnaire questions were recorded. Thirty questions generally consisted of three parts; Part 1; personal information of doctors (age, gender, title, institution, etc.), in section 2; sedative agents used by doctors before and during bronchoscopy and satisfaction with the sedative method used, part 3; preferred follow-up methods during the procedure.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">97</enrollment>
    <condition>Fiberoptic Bronchoscopy</condition>
    <arm_group>
      <arm_group_label>Pulmonologists</arm_group_label>
      <description>pulmonologists actively performing fiberoptic bronchoscopy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey Questions</intervention_name>
      <description>Thirty questions generally consist of three parts; In the first part, there are 8 questions containing the personal information of the doctors (age, gender, title, institution, etc.). In the second part, 13 questions were included in order to make a general assessment such as the sedative agents used by the doctors before and during the bronchoscopy procedure and the satisfaction with the sedative method used. In the third part, 9 questions were given to determine the preferred follow-up methods during the procedure.</description>
      <arm_group_label>Pulmonologists</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pulmonologists who are still working in Turkey and have been actively doing FOB for the&#xD;
          last 5 years&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Currently working as a pulmonologist&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not actively performing fiberoptic bronchoscopy for the past five years&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Dilan Akyurt</name>
        <address>
          <city>Samsun</city>
          <zip>55270</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.</citation>
      <PMID>22045879</PMID>
    </reference>
    <reference>
      <citation>Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.</citation>
      <PMID>23860341</PMID>
    </reference>
    <reference>
      <citation>Gaisl T, Bratton DJ, Heuss LT, Kohler M, Schlatzer C, Zalunardo MP, Frey M, Franzen D. Sedation during bronchoscopy: data from a nationwide sedation and monitoring survey. BMC Pulm Med. 2016 Aug 5;16(1):113. doi: 10.1186/s12890-016-0275-4.</citation>
      <PMID>27495824</PMID>
    </reference>
    <reference>
      <citation>Hautmann H, Hetzel J, Eberhardt R, Stanzel F, Wagner M, Schneider A, Dirschinger R, Poszler A. Cross-Sectional Survey on Bronchoscopy in Germany--The Current Status of Clinical Practice. Pneumologie. 2016 Feb;70(2):110-6. doi: 10.1055/s-0041-110288. Epub 2016 Feb 19.</citation>
      <PMID>26894392</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Samsun University</investigator_affiliation>
      <investigator_full_name>dilan akyurt</investigator_full_name>
      <investigator_title>Principle investigator</investigator_title>
    </responsible_party>
    <keyword>sedation</keyword>
    <keyword>non-operating room anesthesia</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000995
  org study id: B.30.2.ODM.0.20.08/340
  nct id: NCT06000995
  lead sponsor: 
  Fiberoptic bronchoscopy (FOB), which is difficult to tolerate while awake, is recommended to
        be performed by the patient under sedation. The aim of this study is to determine the
        attitudes and behaviors of chest diseases specialists who do FOB in Turkey about sedation
        with a 30-question online questionnaire.
  Fiberoptic bronchoscopy is the imaging of the tracheobronchial tree for diagnosis and
        treatment in lung diseases. The operation performed through the airway is difficult for the
        patient to tolerate. Therefore, it is recommended to perform the procedure under sedation.
        With this survey study, it was aimed to determine the sedation protocols preferred by
        pulmonologists who perform active fiberoptic bronchoscopy throughout Turkey during the
        procedure.
  
        Thirty questions were determined for the questionnaire to be used as a data collection method
        by the researchers. The questions generally consist of three parts; In the first part, there
        are 8 questions containing the personal information of the doctors (age, gender, title,
        institution, etc.). In the second part, 13 questions were included in order to make a general
        assessment such as the sedative agents used by the doctors before and during the bronchoscopy
        procedure, and the satisfaction with the sedative method used. In the third part, 9 questions
        were given to determine the preferred follow-up methods during the procedure. The questions
        are designed to be presented to participants over the network using google forms.
  observational model: Cohort
  time perspective: Prospective
  measure: FOB related survey questions
  time frame: 15 minutes
  description: The pulmonologists' responses to 30 questionnaire questions were recorded. Thirty questions generally consisted of three parts; Part 1; personal information of doctors (age, gender, title, institution, etc.), in section 2; sedative agents used by doctors before and during bronchoscopy and satisfaction with the sedative method used, part 3; preferred follow-up methods during the procedure.
  arm group label: Pulmonologists
  description: pulmonologists actively performing fiberoptic bronchoscopy
  intervention type: Other
  intervention name: Survey Questions
  description: Thirty questions generally consist of three parts; In the first part, there are 8 questions containing the personal information of the doctors (age, gender, title, institution, etc.). In the second part, 13 questions were included in order to make a general assessment such as the sedative agents used by the doctors before and during the bronchoscopy procedure and the satisfaction with the sedative method used. In the third part, 9 questions were given to determine the preferred follow-up methods during the procedure.
  arm group label: Pulmonologists
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  citation: Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.
  PMID: 22045879
  citation: Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.
  PMID: 23860341
  citation: Gaisl T, Bratton DJ, Heuss LT, Kohler M, Schlatzer C, Zalunardo MP, Frey M, Franzen D. Sedation during bronchoscopy: data from a nationwide sedation and monitoring survey. BMC Pulm Med. 2016 Aug 5;16(1):113. doi: 10.1186/s12890-016-0275-4.
  PMID: 27495824
  citation: Hautmann H, Hetzel J, Eberhardt R, Stanzel F, Wagner M, Schneider A, Dirschinger R, Poszler A. Cross-Sectional Survey on Bronchoscopy in Germany--The Current Status of Clinical Practice. Pneumologie. 2016 Feb;70(2):110-6. doi: 10.1055/s-0041-110288. Epub 2016 Feb 19.
  PMID: 26894392
  responsible party type: Principal Investigator
  investigator affiliation: Samsun University
  investigator full name: dilan akyurt
  investigator title: Principle investigator