Bronchoscopy Registry

• Conditions: Indications for Flexible Bronchoscopy
• Interventions: Procedure: Indication for a flexible bronchoscopy

• Registration Number: NCT02741089
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-18
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indication for a flexible bronchoscopy	Indication for a flexible bronchoscopy	Patients representing to the hospital with the indication for a flexible bronchoscopy

Primary Outcome Measures

Name	Time	Method
indication for flexible bronchoscopy	10 minutes (before the routine intervention)	physiological parameters to assure internal quality control regarding the flexible bronchoscopy
demographic data	20 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
duration of medical examination	30 minutes (during the 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
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
grade of amnesia	5 minutes (after routine intervention)	questionnaire
medication (e.g. midazolam, fentanyl, propofol, lidocain)	5 minutes (after routine intervention)	physiological parameters to assure internal quality control regarding the flexible bronchoscopy
acceptance for later bronchoscopies	5 minutes (after routine intervention)	questionnaire

Secondary Outcome Measures

Name	Time	Method
identification of prognostic factors related to complications	30 minutes (during the routine intervention)

Trial Locations

Locations (1)

University Hospital Aachen, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine; 🇩🇪 Aachen, NRW, Germany