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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02262442

Acronym

EnkAtomizerII

Enrollment

Registered

2014-10-13

Start date

2014-10-31

Completion date

2016-08-31

Last updated

2016-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flexible Bronchoscopy

Keywords

flexible bronchoscopy, anaesthetics, transcutaneous pCO2, capillary pCO2, special atomizing set

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.

Interventions

DEVICEEnk Fiberoptic Atomizer

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

DEVICEbronchoscope

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Contacts

Primary ContactTobias Müller, Dr. med.

tobmueller@ukaachen.de+49 241 80 36470

Backup ContactAngela Habier, M.Sc.

ahabier@ukaachen.de+49 241 80 37429

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026