Bronchoscopy Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bronchoscopy Registry

Conditions
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Indications for Flexible Bronchoscopy

Intervention / Treatment
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* Procedure: Indication for a flexible bronchoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indication for a flexible bronchoscopy<br>Patients representing to the hospital with the indication for a flexible bronchoscopy | Procedure: Indication for a flexible bronchoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demographic data | Physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 20 minutes (before the routine intervention) | 
| indication for flexible bronchoscopy | physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 10 minutes (before the routine intervention) | 
| smoking behaviour | physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 1 minute (before the routine intervention) | 
| relevant side diseases | physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 10 minutes (before the routine intervention) | 
| lung function parameters | physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 30 minutes (before the routine intervention) | 
| anesthetic risk (ASA-Score) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 10 minutes (before the routine intervention) | 
| vital signs | physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 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 | 30 minutes (during the routine intervention) | 
| duration of medical examination | physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 30 minutes (during the routine intervention) | 
| medication (e.g. midazolam, fentanyl, propofol, lidocain) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy | 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 | 5 minutes (after routine intervention) | 
| grade of amnesia | questionnaire | 5 minutes (after routine intervention) | 
| acceptance for later bronchoscopies | questionnaire | 5 minutes (after routine intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of prognostic factors related to complications |  | 30 minutes (during the routine intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgosedation, Internal Quality Assurance