Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer During the Bronchoscopy

Phase 4

• Conditions: Flexible Bronchoscopy
• Interventions: Device: bronchoscope; Device: Enk Fiberoptic Atomizer

• Registration Number: NCT02262442
• Lead Sponsor: RWTH Aachen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-18
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Working channel	bronchoscope	Patients will receive local anaesthetics via the working channel of the bronchoscope.
Enk Fiberoptic Atomizer	Enk Fiberoptic Atomizer	Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer.

Primary Outcome Measures

Name	Time	Method
Amount of anaesthetics during flexible bronchoscopy	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.

Secondary Outcome Measures

Name	Time	Method
pCO2	two hours	Determination of: maximum transcutaneous pCO2 during bronchoscopy, mean transcutaneous pCO2 during bronchoscopy, capillary pCO2 immediately after bronchoscopy and 2 hours later, time to Aldrete Score of at least 9 after procedure

Trial Locations

Locations (1)

Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital; 🇩🇪 Aachen, North Rhine-Westphalia, Germany