Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer on Usage of Anaesthetics and Sedatives During the Bronchoscopy

RWTH Aachen University1 site in 1 country60 target enrollmentOctober 2014

ConditionsFlexible Bronchoscopy

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Flexible Bronchoscopy
Sponsor: RWTH Aachen University
Enrollment: 60
Locations: 1
Primary Endpoint: Amount of anaesthetics during flexible bronchoscopy
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this prospective study is to examine the benefits and risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

August 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

RWTH Aachen University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic purposes (seed extraction in unclear infiltrates, interstitial lung disease, unexplained pulmonary opacities, inspection at hemoptysis)
•patients aged 18 years or above
•written informed consent prior to study participation

Exclusion Criteria

•known allergy to local anesthetics, midazolam or propofol, known epilepsy, known severe neurological or psychiatric disorder, hemodynamic instability with need for vasopressor therapy, acute or chronic decompensated heart failure, respiratory failure with the need for oxygen supplementation of more than 2 l per minute at rest (pO2 \> 55 mmHg) or pCO2 \> 50 mmHg at ambient air, known upper airway anomalies, surgery or irradiation of the upper airways in the past, contraindication for transbronchial biopsy as published by international guidelines, e. g. bleeding disorders or severe pulmonary hypertension
•women, who are pregnant or breastfeeding
•alcohol or drug abuse
•expected non-compliance
•patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
•Participation on another clinical trial within the last 3 months
•subjects who are committed to an institution and/or penitentiary by judicial or official order.
•employees of the investigator cooperation companies.

Outcomes

Primary Outcomes

Amount of anaesthetics during flexible bronchoscopy

Time Frame: one hour

Validation of the total amount of administered propofol (mg) during the flexible bronchoscopy. Usage of sedatives other than propofol (midazolam), total amount of administered lidocaine, duration of bronchoscopy.