AuraOnce Performance Observation

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: Placement of laryngeal mask

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 Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ambu A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Actual): November 5, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CIS-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No