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

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

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.

Study Overview

• Status: Unknown
• Conditions: Flexible Bronchoscopy
• Intervention / Treatment: Device: bronchoscope; Device: Enk Fiberoptic Atomizer

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tobias Müller, Dr. med.; Phone Number: +49 241 80 36470; Email: tobmueller@ukaachen.de
• Study Contact Backup: Name: Angela Habier, M.Sc.; Phone Number: +49 241 80 37429; Email: ahabier@ukaachen.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Aachen, North Rhine-Westphalia, Germany, 52074
      • Recruiting
      • Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
      • Contact: Tobias Müller, Dr. med.; Phone Number: +49 241 80 36470; Email: tobmueller@ukaachen.de
      • Contact: Angela Habier, M.Sc.; Phone Number: +49 241 80 37429; Email: ahabier@ukaachen.de
      • Principal Investigator: Tobias Müller, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Working channel; Patients will receive local anaesthetics via the working channel of the bronchoscope.	Device: bronchoscope; Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy
Experimental: Enk Fiberoptic Atomizer; Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer.	Device: Enk Fiberoptic Atomizer; Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy; Other Names: Enk Fiberoptic Atomizer Set, Cook Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of anaesthetics during flexible bronchoscopy	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.	one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCO2	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	two hours

Collaborators and Investigators

• Sponsor: RWTH Aachen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: February 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: anaesthetics; flexible bronchoscopy; transcutaneous pCO2; capillary pCO2; special atomizing set
• Other Study ID Numbers: 14-074; EK 177/14 (Other Identifier: Ethics Committee University Hospital Aachen)