Prospective Non-interventional Evaluation of Insertion and Sealing Performance of AuraOnce Disposable Laryngeal Mask US Version
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anesthesia
- Sponsor
- Ambu A/S
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Number of Participants With Leakage Observed During Procedure
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Leakage Observed During Procedure
Time Frame: During procedure, less than 1 hour
Is leakage observed (yes/no) if yes, insert signs of leakage
Secondary Outcomes
- Number of Participants Where Tip of the Mask is Folded(During procedure, less than one hour)
- 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))(During procedure, less than 1 hour)
- 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(During procedure, less than 1 hour)