Bronchoscopy Registry

Indications for Flexible Bronchoscopy Clinical Trial

— BSK  

Official title:

Bronchoscopy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02741089
• Other study ID #: 15-149
• Status: Recruiting
• Start date: February 2016
• Est. completion date: February 2020

Study information

• Verified date: September 2019
• Source: RWTH Aachen University
• Contact: Tobias Müller
• Phone: 00492418035768
• Email: tobmueller[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Indications for Flexible Bronchoscopy

Intervention

Procedure:
• Indication 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.

Locations

Country	Name	City	State
Germany	University Hospital Aachen, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

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