Lead Sponsor: RWTH Aachen University
|Source||RWTH Aachen University|
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.
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
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.
|Start Date||February 2016|
|Completion Date||February 2020|
|Primary Completion Date||February 2020|
Intervention Type: Procedure
Intervention Name: Indication for a flexible bronchoscopy
Description: 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.
Arm Group Label: Indication for a flexible bronchoscopy
Sampling Method: Non-Probability Sample
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
- Written declaration of consent
- Patients with the medical indication for a flexible bronchoscopy
- 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
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Last Name: Tobias Müller
Email: [email protected]
|Has Expanded Access||No|
Label: Indication for a flexible bronchoscopy
Description: Patients representing to the hospital with the indication for a flexible bronchoscopy
|Study Design Info||
Observational Model: Cohort
Time Perspective: Prospective