Clinical trial NCT02741089: Bronchoscopy Registry
Official title: Bronchoscopy Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Indications for Flexible Bronchoscopy
Keywords: Analgosedation
Internal Quality Assurance
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the medical indication for a flexible bronchoscopy by the attending physicians

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Written declaration of consent
* Patients with the medical indication for a flexible bronchoscopy

Exclusion Criteria:

* 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

Primary outcomes:
measure: demographic data
timeFrame: 20 minutes (before the routine intervention)
measure: indication for flexible bronchoscopy
timeFrame: 10 minutes (before the routine intervention)
measure: smoking behaviour
timeFrame: 1 minute (before the routine intervention)
measure: relevant side diseases
timeFrame: 10 minutes (before the routine intervention)
measure: lung function parameters
timeFrame: 30 minutes (before the routine intervention)
measure: anesthetic risk (ASA-Score)
timeFrame: 10 minutes (before the routine intervention)
measure: vital signs
timeFrame: 10 minutes (before and after the routine intervention)
measure: detection of complications depending on the different analgosedations
timeFrame: 30 minutes (during the routine intervention)
measure: duration of medical examination
timeFrame: 30 minutes (during the routine intervention)
measure: medication (e.g. midazolam, fentanyl, propofol, lidocain)
timeFrame: 5 minutes (after routine intervention)
measure: general tolerance for the procedure and different symptoms like emesis, feeling of suffocation, cough and pain (0 = no stress, 100 = intolerable)
timeFrame: 5 minutes (after routine intervention)
measure: grade of amnesia
timeFrame: 5 minutes (after routine intervention)
measure: acceptance for later bronchoscopies
timeFrame: 5 minutes (after routine intervention)
Secondary outcomes:
measure: identification of prognostic factors related to complications
timeFrame: 30 minutes (during the routine intervention)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine
state: NRW
Study officials:
affiliation: RWTH Aachen University Hospital, MK1
name: Michael Dreher, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: RWTH Aachen University Hospital, MK1
name: Tobias Müller, PD
role: PRINCIPAL_INVESTIGATOR
References: