Effect of the EnkFiberoptic Atomizer Set on Usage of Anaesthetics During the Bronchoscopy

NCT ID: NCT01969045

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-02-29

Brief Summary

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.

Conditions

Administration of Local Anaesthetics With a Special Atomizing Set Durching Fexible Bronchoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Working channel

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

Group Type: EXPERIMENTAL

bronchoscope

Intervention Type: DEVICE

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

Enk Fiberoptic Atomizer

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

Group Type: EXPERIMENTAL

Enk Fiberoptic Atomizer

Intervention Type: DEVICE

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

Interventions

Enk Fiberoptic Atomizer

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

Intervention Type: DEVICE

bronchoscope

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

Intervention Type: DEVICE

Other Intervention Names

Enk Fiberoptic Atomizer Set, Cook Medical

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Müller, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

EK 222/13

Identifier Type: OTHER

Identifier Source: secondary_id

13-103

Identifier Type: -

Identifier Source: org_study_id