| Registry | NCT01969045, acronym EnkAtomizer |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, basic science |
| Enrollment | 30 (Actual) |
| Sponsor | RWTH Aachen University (Other) |
| Conditions | Administration of Local Anaesthetics With a Special Atomizing Set Durching Fexible Bronchoscopy |
| Interventions | Enk Fiberoptic Atomizer, bronchoscope (Device) |
| Dates | start 2014-02-01, primary completion 2016-02-01, completion 2016-02-01, first posted 2013-10-24, last updated 2016-02-18 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Administration of Local Anaesthetics With a Special Atomizing Set Durching Fexible Bronchoscopy All trials of Enk Fiberoptic Atomizer All trials of bronchoscope
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Working channel | Experimental | Device: bronchoscope | Patients will receive local anaesthetics via the working channel of the bronchoscope. |
| Enk Fiberoptic Atomizer | Experimental | Device: Enk Fiberoptic Atomizer | Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer. |
Sex: All, ages: 18 Years to 85 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital | Aachen, North Rhine-Westphalia | Germany |