AuraOnce Performance Observation

Completed

• Conditions: Anesthesia

• Registration Number: NCT04128527
• Lead Sponsor: Ambu A/S

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.

Study Timeline

• Study Start: 2019-10-09
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Primary Completion: 2019-11-05
• Study Completion: 2019-11-05
• Status Verified: 2021-08
• Results First Submitted: 2021-08-02
• Results First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Results First Posted: 2021-11-03
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Leakage Observed During Procedure	During procedure, less than 1 hour	Is leakage observed (yes/no) if yes, insert signs of leakage

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark