Status:
UNKNOWN
Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer During the Bronchoscopy
Lead Sponsor:
RWTH Aachen University
Conditions:
Flexible Bronchoscopy
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 bron...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02262442
Start Date
October 1 2014
End Date
August 1 2016
Last Update
February 18 2016
Active Locations (1)
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1
Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, Germany, 52074