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

NCT02262442 — Phase 4, Unknown, 60 participants, RWTH Aachen University

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

Registry	NCT02262442, acronym EnkAtomizerII
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, basic science
Enrollment	60 (Estimated)
Sponsor	RWTH Aachen University (Other)
Conditions	Flexible Bronchoscopy
Interventions	Enk Fiberoptic Atomizer, bronchoscope (Device)
Dates	start 2014-10-01, primary completion 2016-08-01 (estimated), completion 2016-08-01 (estimated), first posted 2014-10-13, last updated 2016-02-18
Locations	1 site in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Working channel	Experimental	Device: bronchoscope	Patients will receive local anaesthetics via the working channel of the bronchoscope.
Enk Fiberoptic Atomizer	Experimental	Device: Enk Fiberoptic Atomizer	Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer.

Enk Fiberoptic Atomizer (Device), also known as Enk Fiberoptic Atomizer Set, Cook Medical: Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy
bronchoscope (Device): Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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.

+Locations (1)

Facility	City	Country	Status
Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital	Aachen, North Rhine-Westphalia	Germany	Recruiting

+Publications

Results publication: Muller T, Cornelissen C, Dreher M. Nebulization versus standard application for topical anaesthesia during flexible bronchoscopy under moderate sedation - a randomized controlled trial. Respir Res. 2018 Nov 21;19(1):227. doi: 10.1186/s12931-018-0926-5. PMID 30463577

+Investigators

Tobias Müller, Dr. med., Principal investigator, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital