Fiberoptic BronchoscopyNCT06000995
Determination of Fiberoptic Bronchoscopy Sedation Protocols in Turkey
An observational study of Fiberoptic Bronchoscopy, run by Samsun University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fiberoptic Bronchoscopy
- What is being tested?
- Survey Questions
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pulmonologists who are still working in Turkey and have been actively doing FOB for the last 5 years
Who may be able to join
- Currently working as a pulmonologist
Who cannot join
- Not actively performing fiberoptic bronchoscopy for the past five years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Fiberoptic Bronchoscopy Sedation Protocols; Survey Study on Sedation Attitudes and Behaviors of Chest Diseases Specialists in Turkey
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.
Read the detailed 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.
- Conditions
- Fiberoptic Bronchoscopy
- Being tested
- Survey Questions
- Keywords
- sedation, non-operating room anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey QuestionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonologists | pulmonologists actively performing fiberoptic bronchoscopy Receives: Other: Survey Questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start16 May 2022
- Primary completion30 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fiberoptic BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilan akyurt, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000995
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/340
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
Publications
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.
PubMed 22045879Du 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.
PubMed 23860341Gaisl 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.
PubMed 27495824Hautmann 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.
PubMed 26894392
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Fiberoptic Bronchoscopy Sedation Protocols; Survey Study on Sedation Attitudes and Behaviors of Chest Diseases Specialists in Turkey
- ClinicalTrials.gov ID
- NCT06000995
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/340
- Conditions
- Fiberoptic Bronchoscopy
- Keywords
- sedation, non-operating room anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonologists | – | Other: Survey Questionspulmonologists actively performing fiberoptic bronchoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonologists who are still working in Turkey and have been actively doing FOB for the last 5 years
Key inclusion criteria (1 listed)
- Currently working as a pulmonologist
Key exclusion criteria (1 listed)
- Not actively performing fiberoptic bronchoscopy for the past five years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey QuestionsThirty 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. | Other | Pulmonologists |
Primary outcome
FOB related survey questions
Time frame: 15 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 22045879Wahidi 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.
- Background: PubMed 23860341Du 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.
- Background: PubMed 27495824Gaisl 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.
- Background: PubMed 26894392Hautmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fiberoptic Bronchoscopy, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FOB related survey questions (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000995, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.