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

Study Overview
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Brief Summary
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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.

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

Conditions
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Flexible Bronchoscopy

Intervention / Treatment
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* Device: Enk Fiberoptic Atomizer
* Device: bronchoscope


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Working channel<br>Patients will receive local anaesthetics via the working channel of the bronchoscope. | Device: bronchoscope<br>* Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy<br>|
| Experimental: Enk Fiberoptic Atomizer<br>Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer. | Device: Enk Fiberoptic Atomizer<br>* Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy<br>* Other names: Enk Fiberoptic Atomizer Set, Cook Medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flexible bronchoscopy, anaesthetics, transcutaneous pCO2, capillary pCO2, special atomizing set