Summative Evaluation to Validate the LEAFix Device With Users (LEAFIXUser)

Liverpool University Hospitals NHS Foundation Trust

Status: Unknown

Conditions: Anesthesia

Treatments: Other: nil intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05255432

SP0920

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Member of staff trained in placing airways

Exclusion criteria

• Previous knowledge of the device

Trial design

32 participants in 2 patient groups

Group A

Description:

Selection of tasks

Treatment:

Other: nil intervention

Group B

Description:

Selection of tasks

Treatment:

Other: nil intervention