Effect of the EnkFiberoptic Atomizer Set on Usage of Anaesthetics During the Bronchoscopy (EnkAtomizer)

The aim of this prospective study is to examine the benefits und risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.

Study Overview

• Status: Completed
• Conditions: Administration of Local Anaesthetics With a Special Atomizing Set Durching Fexible Bronchoscopy
• Intervention / Treatment: Device: bronchoscope; Device: Enk Fiberoptic Atomizer

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Aachen, North Rhine-Westphalia, Germany, 52074
      • Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital

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 (suspected lung cancer, interstitial lung disease, unexplained pulmonary opacities)
• hospitalized patients
• 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
• 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 felxible 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 felxible 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 fexible bronchoscopy	Valdiation of the total amount of administered propofol (mg) during the fexible 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

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (ESTIMATE): October 24, 2013

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; transcutaneous pCO2; capillary pCO2; felxible bronchoscopy
• Other Study ID Numbers: 13-103; EK 222/13 (OTHER: Ethics Committee University Hospital Aachen)