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

Flexible Bronchoscopy Clinical Trial

— EnkAtomizerII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02262442
• Other study ID #: 14-074
• Secondary ID: EK 177/14
• Status: Recruiting
• Phase: Phase 4
• First received: October 7, 2014
• Last updated: February 17, 2016
• Start date: October 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: RWTH Aachen University
• Contact: Tobias Müller, Dr. med.
• Phone: +49 241 80 36470
• Email: tobmueller[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Flexible Bronchoscopy

Intervention

Device:
• Enk Fiberoptic Atomizer
Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy
• bronchoscope
Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No