AuraOnce Performance Observation

Study Overview
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Brief Summary
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This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark. The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019. The intention is to perform a quality assessment of the AuraOnce. Subjects will not be asked to participate in this study as it is a quality study where the AuraOnce is used within its intended use and according to normal clinical procedure.

Detailed Description
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This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark. The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.

Official Title
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Prospective Non-interventional Evaluation of Insertion and Sealing Performance of AuraOnce Disposable Laryngeal Mask US Version

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Placement of laryngeal mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects > 18 years Subjects planned for diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask. Exclusion Criteria: - Subjects where use of AuraOnce cannot be clinically justified

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Placement of laryngeal mask|All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Leakage Observed During Procedure | Is leakage observed (yes/no) if yes, insert signs of leakage | During procedure, less than 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) | Investigator evaluation of ease of insertion on a 5-point scale (very difficult (=1) to very easy (=5)) | During procedure, less than 1 hour | 
| Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) | Investigator evaluation of ease of obtaining seal on a 5-point scale (very difficult (=1) to very easy (=5)) | During procedure, less than 1 hour | 
| Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5)) | Investigator evaluation of overall performance on a 5-point scale (very bad (=1) to excellent (=5)) | During procedure, less than 1 hour | 
| Number of Participants With Correct Placement of Mask | It is checked if the mask is placed above the vocal cords (yes/no) | During procedure, less than 1 hour | 
| Number of Participants Where Tip of the Mask is Folded | After insertion of the mask, it is assessed by bronchoscopy whether the tip of the mask is folded. Folded tip= Yes, Not folded= No | During procedure, less than one hour |