AuraOnce Performance Observation

Ambu

Status: Completed

Conditions: Anesthesia

Treatments: Device: Placement of laryngeal mask

Study type: Observational

Funder types: Industry

Identifiers

NCT04128527

CIS-016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design