NCT05255432

Summative Evaluation to Validate the LEAFix Device With Users

Summative Evaluation to Validate That the Laryngeal, Endo-tracheal, Airway Fixator (LEAFix) Can be Used Safely and Effectively by Intended Users to Secure Airway Devices

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 32 (estimated)
• Sponsor: Liverpool University Hospitals NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The Laryngeal Endo-tracheal Airway Fixator(LEAFix) is a single use product designed to secure airway devices to patients during anaesthesia, with better infection control management and interaction with the patients skin. This study investigates the users of the LEAFix device interacting with the LEAFix device, its packaging and a simulated patient through different scenarios of securing an airway device. The aim is to understand the risks associated with the use of the device for CE marking purposes. This study is funded by Innovel Ltd. the manufacturer of the device.

Conditions

• Anesthesia

Interventions

Type	Name	Description
OTHER	nil intervention	Users observation using medical device on manakin, different scenarios per group

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-08-01
• Completion: 2022-09-01
• First posted: 2022-02-24
• Last updated: 2022-05-11