Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-29 @ 2:23 PM
Study NCT ID:
NCT06000995
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Fiberoptic Bronchoscopy Sedation Protocols in Turkey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-13', 'studyFirstSubmitDate': '2023-07-29', 'studyFirstSubmitQcDate': '2023-08-13', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FOB related survey questions', 'timeFrame': '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."}]}, 'conditionsModule': {'keywords': ['sedation', 'non-operating room anesthesia'], 'conditions': ['Fiberoptic Bronchoscopy']}, 'referencesModule': {'references': [{'pmid': '22045879', 'type': 'BACKGROUND', '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': '23860341', 'type': 'BACKGROUND', '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': '27495824', 'type': 'BACKGROUND', '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': '26894392', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThirty 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pulmonologists who are still working in Turkey and have been actively doing FOB for the last 5 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently working as a pulmonologist\n\nExclusion Criteria:\n\n* Not actively performing fiberoptic bronchoscopy for the past five years'}, 'identificationModule': {'nctId': 'NCT06000995', 'briefTitle': 'Determination of Fiberoptic Bronchoscopy Sedation Protocols in Turkey', 'organization': {'class': 'OTHER', 'fullName': 'Samsun University'}, 'officialTitle': 'Determination of Fiberoptic Bronchoscopy Sedation Protocols; Survey Study on Sedation Attitudes and Behaviors of Chest Diseases Specialists in Turkey', 'orgStudyIdInfo': {'id': 'B.30.2.ODM.0.20.08/340'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonologists', 'description': 'pulmonologists actively performing fiberoptic bronchoscopy', 'interventionNames': ['Other: Survey Questions']}], 'interventions': [{'name': 'Survey Questions', 'type': 'OTHER', '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.', 'armGroupLabels': ['Pulmonologists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55270', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Dilan Akyurt', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'dilan akyurt', 'investigatorAffiliation': 'Samsun University'}}}}