Bronchoscopy Registry (BSK)

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.

Study Overview

• Status: Unknown
• Conditions: Indications for Flexible Bronchoscopy
• Intervention / Treatment: Procedure: Indication for a flexible bronchoscopy

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Recruiting
      • University Hospital Aachen, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine
      • Contact: Tobias Müller, PD; Phone Number: 36470 004924180; Email: tobmueller@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with the medical indication for a flexible bronchoscopy by the attending physicians

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Indication for a flexible bronchoscopy; Patients representing to the hospital with the indication for a flexible bronchoscopy

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
identification of prognostic factors related to complications	30 minutes (during the routine intervention)

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Michael Dreher, Prof. Dr., RWTH Aachen University Hospital, MK1; Principal Investigator: Tobias Müller, PD, RWTH Aachen University Hospital, MK1

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): February 1, 2020

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (ESTIMATE): April 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Analgosedation; Internal Quality Assurance
• Other Study ID Numbers: 15-149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED