Bronchoscopy Registry

NCT ID: NCT02741089

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-02-29

Brief Summary

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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

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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.

Conditions

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Indications for Flexible Bronchoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Indication for a flexible bronchoscopy

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

Indication for a flexible bronchoscopy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Written declaration of consent
* Patients with the medical indication for a flexible bronchoscopy

* 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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Dreher, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University Hospital, MK1

Tobias Müller, PD

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University Hospital, MK1

Locations

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University Hospital Aachen, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine

Aachen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Tobias Müller

Role: CONTACT

00492418035768

Angela Habier

Role: CONTACT

004924180 ext. 37429

Facility Contacts

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Tobias Müller, PD

Role: primary

004924180 ext. 36470

Angela Habier

Role: backup

004924180 ext. 37429

Other Identifiers

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15-149

Identifier Type: -

Identifier Source: org_study_id

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