Indications for Flexible BronchoscopyBSKNCT02741089
Bronchoscopy Registry
An observational study of Indications for Flexible Bronchoscopy, run by RWTH Aachen University at 1 site in Germany.
Trial summary
This monocentric, non-interventional observational registry study was designed in order to obtain data of patients with the indication for a flexible bronchoscopy to control and optimize a guideline conform therapy of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indications for Flexible Bronchoscopy
- What is being tested?
- Indication for a flexible bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the medical indication for a flexible bronchoscopy by the attending physicians
Who may be able to join
- Written declaration of consent
- Patients with the medical indication for a flexible bronchoscopy
Who cannot join
- Patients who are not fulfilling the inclusion criteria or:
- Pregnant or breastfeeding women
- Participation in other studies
- Sponsor-dependent patients or patients who are working with the sponsor
- Patients without mental ability or capacity to understand and follow the instructions of the investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Aachen, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine
Aachen, North Rhine-Westphalia, 52074
Tobias Müller, PD, 004924180 ext. 36470, tobmueller@ukaachen.de
Angela Habier, 004924180 ext. 37429, ahabier@ukaachen.de
About this study
This monocentric, non-interventional observational registry study was designed in order to obtain data of patients with the indication for a flexible bronchoscopy to control and optimize a guideline conform therapy of these patients.
Read the detailed description
Aims of this registry study are documentation of the characteristics of all patients with an indication for a flexible bronchoscopy who are attended at the University Hospital Aachen (UKA) to obtain new knowledge concerning safety and patient comfort using different medications for sedation.
Therefore a routine flexible bronchoscopy is carried out, whereat the choice of analgosedation medication is for the investigators decision, independent from the study.
Subsequently the following data are collected:
- duration of medical examination
- medication (e.g. midazolam, fentanyl, propofol, lidocain)
- vital signs at the end of the examination
- complications
Furthermore the patient should be asked concerning the general tolerance for the procedure and different symptoms like emesis, feeling of suffocation, cough and pain (0 = no stress, 100 = intolerable). In addition to that the grade of amnesia and the acceptance for later bronchoscopies should be asked.
Analyzing this data will optimize the internal quality control concerning the conducted examination, collect all complications related to the analgosedation and enhance the patients comfort during a flexible bronchoscopy.
- Conditions
- Indications for Flexible Bronchoscopy
- Being tested
- Indication for a flexible bronchoscopy
- Keywords
- Analgosedation, Internal Quality Assurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indication for a flexible bronchoscopyProcedure or surgery
The data of patients are collected within the hospital routine documentation during the flexible bronchoscopy. The bronchoscopy is performed regardless of this study. Following the bronchoscopy the patients are asked a few questions about their health and their perception.
The follow-up of all patients is done via phone calls in order to collect data about the outcome of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Indication for a flexible bronchoscopy | Patients representing to the hospital with the indication for a flexible bronchoscopy Receives: Procedure: Indication for a flexible bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
demographic data
Physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 20 minutes (before the routine intervention)
indication for flexible bronchoscopy
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 10 minutes (before the routine intervention)
smoking behaviour
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 1 minute (before the routine intervention)
relevant side diseases
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 10 minutes (before the routine intervention)
lung function parameters
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 30 minutes (before the routine intervention)
anesthetic risk (ASA-Score)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 10 minutes (before the routine intervention)
vital signs
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 10 minutes (before and after the routine intervention)
detection of complications depending on the different analgosedations
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 30 minutes (during the routine intervention)
duration of medical examination
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 30 minutes (during the routine intervention)
medication (e.g. midazolam, fentanyl, propofol, lidocain)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
Measured: 5 minutes (after routine intervention)
general tolerance for the procedure and different symptoms like emesis, feeling of suffocation, cough and pain (0 = no stress, 100 = intolerable)
questionnaire
Measured: 5 minutes (after routine intervention)
grade of amnesia
questionnaire
Measured: 5 minutes (after routine intervention)
acceptance for later bronchoscopies
questionnaire
Measured: 5 minutes (after routine intervention)
Secondary outcomes (1)
identification of prognostic factors related to complications
Measured: 30 minutes (during the routine intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indications for Flexible 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dreher, Prof. Dr., Principal investigator, RWTH Aachen University Hospital, MK1Tobias Müller, PD, Principal investigator, RWTH Aachen University Hospital, MK1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741089
- Sponsor's protocol ID
- 15-149
- Acronym
- BSK
- Status last verified
- Sep 2019
- First submitted
- 17 Feb 2016
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopy Registry
- ClinicalTrials.gov ID
- NCT02741089
- Acronym / sponsor ID
- BSK / 15-149
- Conditions
- Indications for Flexible Bronchoscopy
- Keywords
- Analgosedation, Internal Quality Assurance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 18 Apr 2016 (estimated)
- 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.
This monocentric, non-interventional observational registry study was designed in order to obtain data of patients with the indication for a flexible bronchoscopy to control and optimize a guideline conform therapy of these patients.
Detailed description
Aims of this registry study are documentation of the characteristics of all patients with an indication for a flexible bronchoscopy who are attended at the University Hospital Aachen (UKA) to obtain new knowledge concerning safety and patient comfort using different medications for sedation.
Therefore a routine flexible bronchoscopy is carried out, whereat the choice of analgosedation medication is for the investigators decision, independent from the study.
Subsequently the following data are collected:
- duration of medical examination
- medication (e.g. midazolam, fentanyl, propofol, lidocain)
- vital signs at the end of the examination
- complications
Furthermore the patient should be asked concerning the general tolerance for the procedure and different symptoms like emesis, feeling of suffocation, cough and pain (0 = no stress, 100 = intolerable). In addition to that the grade of amnesia and the acceptance for later bronchoscopies should be asked.
Analyzing this data will optimize the internal quality control concerning the conducted examination, collect all complications related to the analgosedation and enhance the patients comfort during a flexible bronchoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indication for a flexible bronchoscopy | – | Procedure: Indication for a flexible bronchoscopyPatients representing to the hospital with the indication for a flexible bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the medical indication for a flexible bronchoscopy by the attending physicians
Key inclusion criteria (2 listed)
- Written declaration of consent
- Patients with the medical indication for a flexible bronchoscopy
Key exclusion criteria (5 listed)
- Patients who are not fulfilling the inclusion criteria or:
- Pregnant or breastfeeding women
- Participation in other studies
- Sponsor-dependent patients or patients who are working with the sponsor
- Patients without mental ability or capacity to understand and follow the instructions of the investigator
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 |
|---|---|---|
| Indication for a flexible bronchoscopyThe data of patients are collected within the hospital routine documentation during the flexible bronchoscopy. The bronchoscopy is performed regardless of this study. Following the bronchoscopy the patients are asked a few questions about their health and their perception. The follow-up of all patients is done via phone calls in order to collect data about the outcome of each patient. | Procedure or surgery | Indication for a flexible bronchoscopy |
Primary outcome
demographic data
Time frame: 20 minutes (before the routine intervention)
Physiological parameters to assure internal quality control regarding the flexible bronchoscopy
indication for flexible bronchoscopy
Time frame: 10 minutes (before the routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
smoking behaviour
Time frame: 1 minute (before the routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
relevant side diseases
Time frame: 10 minutes (before the routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
lung function parameters
Time frame: 30 minutes (before the routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
anesthetic risk (ASA-Score)
Time frame: 10 minutes (before the routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
vital signs
Time frame: 10 minutes (before and after the routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
detection of complications depending on the different analgosedations
Time frame: 30 minutes (during the routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
duration of medical examination
Time frame: 30 minutes (during the routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
medication (e.g. midazolam, fentanyl, propofol, lidocain)
Time frame: 5 minutes (after routine intervention)
physiological parameters to assure internal quality control regarding the flexible bronchoscopy
general tolerance for the procedure and different symptoms like emesis, feeling of suffocation, cough and pain (0 = no stress, 100 = intolerable)
Time frame: 5 minutes (after routine intervention)
questionnaire
grade of amnesia
Time frame: 5 minutes (after routine intervention)
questionnaire
acceptance for later bronchoscopies
Time frame: 5 minutes (after routine intervention)
questionnaire
1 secondary outcome
identification of prognostic factors related to complications
Time frame: 30 minutes (during the routine intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: Undecided
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.
Michael Dreher, Prof. Dr. principal investigator
RWTH Aachen University Hospital, MK1
Tobias Müller, PD principal investigator
RWTH Aachen University Hospital, MK1
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 Indications for Flexible Bronchoscopy, run by RWTH Aachen University at 1 site in Germany.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Müller (00492418035768, tobmueller@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demographic data (time frame: 20 minutes (before the routine intervention)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2019; AzTrials last refreshed its copy on 27 Oct 2026.