Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer During the Bronchoscopy (EnkAtomizerII)

RWTH Aachen University

Status and phase: Unknown; Phase 4

Conditions: Flexible Bronchoscopy

Treatments: Device: Enk Fiberoptic Atomizer; Device: bronchoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT02262442

EK 177/14 (Other Identifier)

14-074

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Working channel

Experimental group

Description:

Patients will receive local anaesthetics via the working channel of the bronchoscope.

Treatment:

Device: bronchoscope

Enk Fiberoptic Atomizer

Experimental group

Description:

Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer.

Treatment:

Device: Enk Fiberoptic Atomizer