AuraOnce Performance Observation

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04128527
• Other study ID #: CIS-016
• Status: Completed
• Start date: October 9, 2019
• Est. completion date: November 5, 2019

Study information

• Verified date: August 2021
• Source: Ambu A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Placement of laryngeal mask
All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Ambu A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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