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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06000995
Other study ID # B.30.2.ODM.0.20.08/340
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 16, 2022
Est. completion date July 31, 2022

Study information

Verified date August 2023
Source Samsun University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date July 31, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Currently working as a pulmonologist Exclusion Criteria: - Not actively performing fiberoptic bronchoscopy for the past five years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey Questions
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.

Locations

Country Name City State
Turkey Dilan Akyurt Samsun

Sponsors (1)

Lead Sponsor Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary FOB related survey questions 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. 15 minutes
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