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Status unknownNCT02262442EnkAtomizerIIUpdated Feb 18, 2016

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

A Phase 4 interventional study of Enk Fiberoptic Atomizer and bronchoscope in Flexible Bronchoscopy, sponsored by RWTH Aachen University. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-18.

Sponsored by RWTH Aachen University · Phase 4, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Flexible Bronchoscopy

Keywords

  • flexible bronchoscopy
  • anaesthetics
  • transcutaneous pCO2
  • capillary pCO2
  • special atomizing set
03

In context

Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Working channel

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

    Device: bronchoscope

  • Experimental
    Enk Fiberoptic Atomizer

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

    Device: Enk Fiberoptic Atomizer

Interventions

  • DeviceEnk Fiberoptic Atomizer

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

    Also known as: Enk Fiberoptic Atomizer Set, Cook Medical

  • Devicebronchoscope

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one hour

Secondary outcomes

  1. 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

    Time frame: two hours

07

Study locations

1 of 1 sites recruiting
  • Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
    Aachen, North Rhine-Westphalia 52074, Germany
    • Tobias Müller, Dr. med. · Contact · tobmueller@ukaachen.de · +49 241 80 36470
    • Angela Habier, M.Sc. · Contact · ahabier@ukaachen.de · +49 241 80 37429
    • Tobias Müller, Dr. med. · Principal investigator
    Recruiting
08

References and documents

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. PubMed 30463577 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02262442
Lead sponsor
RWTH Aachen University
Responsible party
Sponsor
First posted
Oct 13, 2014
Start date
Oct 2014
Primary completion
Aug 2016 (estimated)
Completion
Aug 2016 (estimated)
Last update
Feb 18, 2016

Study contacts

Tobias Müller, Dr. med.
Contact
tobmueller@ukaachen.de
+49 241 80 36470
Angela Habier, M.Sc.
Contact
ahabier@ukaachen.de
+49 241 80 37429
Tobias Müller, Dr. med.
principal investigator · Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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