Topical Anesthesia / Bronchoscopy

Study Overview
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Brief Summary
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The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.

Detailed Description
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Patients included in the first half of the study (topical anesthesia with the Laryngeal atomizer) and with need for another bronchoscopy in the second half of the study (topical anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the questionnaire after the second bronchoscopy to allow in-patient comparison. Description of the primary efficacy analysis and population: The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.

Official Title
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Topical Nasopharyngeal Anesthesia in Outpatient Bronchoscopy

Conditions
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Equally of Delivery Systems of Local Anesthesia in Bronchoscopy

Intervention / Treatment
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* Device: topical anesthesia multi-use device
* Device: topical anesthesia Intranasal Mucosal Atomization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients after lung transplantation (single, double or combined) Informed consent outpatient bronchoscopy Exclusion Criteria: Oxygen requirement at rest Need for peri-interventional sedation limited German language skills or other reasons which might impair patient communication or computer handling

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| topical anesthesia multi-use device<br>anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany | Device: topical anesthesia multi-use device<br> <br> * Other names: anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany;|
| topical anesthesia Intranasal Mucosal Atomization<br>single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia | Device: topical anesthesia Intranasal Mucosal Atomization<br> <br> * Other names: single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equally | The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy. | 30 min. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung transplantation, anesthesia, bronchosocopy