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

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

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Flexible Bronchoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Working channel

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

Group Type EXPERIMENTAL

bronchoscope

Intervention Type DEVICE

Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy

Enk Fiberoptic Atomizer

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

Group Type EXPERIMENTAL

Enk Fiberoptic Atomizer

Intervention Type DEVICE

Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy

Interventions

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Enk Fiberoptic Atomizer

Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy

Intervention Type DEVICE

bronchoscope

Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy

Intervention Type DEVICE

Other Intervention Names

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Enk Fiberoptic Atomizer Set, Cook Medical

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No