NCT02262442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

October 7, 2014

Last Update Submit

February 17, 2016

Conditions

Flexible Bronchoscopy

Keywords

flexible bronchoscopyanaestheticstranscutaneous pCO2capillary pCO2special atomizing set

Outcome Measures

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.

    one hour

Secondary Outcomes (1)

  • pCO2

    two hours

Study Arms (2)

Working channel

EXPERIMENTAL

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

Device: bronchoscope

Enk Fiberoptic Atomizer

EXPERIMENTAL

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

Device: Enk Fiberoptic Atomizer

Interventions

Enk Fiberoptic AtomizerDEVICE

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
Enk Fiberoptic Atomizer
bronchoscopeDEVICE

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

Working channel

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (1)

  • 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: 30463577DERIVED

MeSH Terms

Interventions

Bronchoscopes

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Tobias Müller, Dr. med.

    Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Müller, Dr. med.

CONTACT

+49 241 80 36470tobmueller@ukaachen.de

Angela Habier, M.Sc.

CONTACT

+49 241 80 37429ahabier@ukaachen.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 13, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

DE(1)