Bronchoscopy Registry

Bronchoscopy Registry

Sponsors

Lead Sponsor: RWTH Aachen University

Source RWTH Aachen University
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.

Overall Status Recruiting
Start Date February 2016
Completion Date February 2020
Primary Completion Date February 2020
Study Type Observational
Primary Outcome
Measure Time Frame
demographic data 20 minutes (before the routine intervention)
indication for flexible bronchoscopy 10 minutes (before the routine intervention)
smoking behaviour 1 minute (before the routine intervention)
relevant side diseases 10 minutes (before the routine intervention)
lung function parameters 30 minutes (before the routine intervention)
anesthetic risk (ASA-Score) 10 minutes (before the routine intervention)
vital signs 10 minutes (before and after the routine intervention)
detection of complications depending on the different analgosedations 30 minutes (during the routine intervention)
duration of medical examination 30 minutes (during the routine intervention)
medication (e.g. midazolam, fentanyl, propofol, lidocain) 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) 5 minutes (after routine intervention)
grade of amnesia 5 minutes (after routine intervention)
acceptance for later bronchoscopies 5 minutes (after routine intervention)
Secondary Outcome
Measure Time Frame
identification of prognostic factors related to complications 30 minutes (during the routine intervention)
Enrollment 100
Condition
Intervention

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

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Tobias Müller

Phone: 00492418035768

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: University Hospital Aachen, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine Tobias Müller, PD 004924180 36470 [email protected]
Location Countries

Germany

Verification Date

September 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Label: Indication for a flexible bronchoscopy

Description: Patients representing to the hospital with the indication for a flexible bronchoscopy

Acronym BSK
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov