Indications for Flexible Bronchoscopy
Conditions
Keywords
Analgosedation, Internal Quality Assurance
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.
Interventions
PROCEDUREIndication for a flexible bronchoscopy
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.
Sponsors
RWTH Aachen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| grade of amnesia | 5 minutes (after routine intervention) | questionnaire |
| acceptance for later bronchoscopies | 5 minutes (after routine intervention) | questionnaire |
| demographic data | 20 minutes (before the routine intervention) | Physiological parameters to assure internal quality control regarding the flexible bronchoscopy |
| indication for flexible bronchoscopy | 10 minutes (before the routine intervention) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy |
| smoking behaviour | 1 minute (before the routine intervention) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy |
| relevant side diseases | 10 minutes (before the routine intervention) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy |
| lung function parameters | 30 minutes (before the routine intervention) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy |
| anesthetic risk (ASA-Score) | 10 minutes (before the routine intervention) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy |
| vital signs | 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 | 30 minutes (during the routine intervention) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy |
| duration of medical examination | 30 minutes (during the routine intervention) | physiological parameters to assure internal quality control regarding the flexible bronchoscopy |
| medication (e.g. midazolam, fentanyl, propofol, lidocain) | 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) | 5 minutes (after routine intervention) | questionnaire |
Secondary
| Measure | Time frame |
|---|---|
| identification of prognostic factors related to complications | 30 minutes (during the routine intervention) |
Countries
Germany
Contacts
Primary ContactTobias Müller
Backup ContactAngela Habier
Outcome results
None listed