Comparison of Two Different Types of Spray as You go Technique for Awake Fiberoptic Intubation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether modified spray as you go technique using the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for the patient.

Official Title
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Comparative Clinical Trial of Conventional and Modified Spray as You go Technique With the Enk Fiberoptic Atomizer Set for Awake Fiberoptic Intubation (Atomizer Study)

Conditions
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Awake Fiberoptic Intubation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years no concurrent participation in another clinical trial German language in speaking and writing Capability of giving consent written informed consent an elective surgery under general anesthesia, in which an awake fiberoptic intubation is indicated Exclusion Criteria: Age < 18 years pregnant women patients unwilling or unable to give informed consent ASA classification > 3 Known allergy to local anesthetics Participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 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: bronchoscope<br>Patients will receive local anaesthetics via the working channel of the bronchoscope. | Device: bronchoscope<br> <br> * Other names: Standard procedure: Instillation of local anesthetics via the working channel of the bronchoscope;|
| Experimental: Enk Fiberoptic Atomizer<br>Patients will receive local anaesthetics for the awake fiberoptic intubation via the Enk Fiberoptic Atomizer. | Device: Enk Fiberoptic Atomizer<br> <br> * Other names: Nebulization of local anesthetics with the Enk Fiberoptic Atomizer during awake fiberoptic intubation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort evaluation by the patient | Comparison of conventional and modified spray as you go technique | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort evaluation by the performing as well as assisting anesthetist | Comparison of conventional and modified spray as you go technique | up to 4 weeks | 
| Comfort evaluation by the present nurses | Comparison of conventional and modified spray as you go technique | up to 4 weeks | 
| Patient response (coughing, gagging, grimacing, defenses) | Comparison of conventional and modified spray as you go technique | up to 4 weeks | 
| Vital signs | Comparison of conventional and modified spray as you go technique | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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awake fiberoptic intubation, spray as you go technique, anesthesia, Enk Fiberoptic Atomizer Set