Summative Evaluation to Validate the LEAFix Device With Users

• Conditions: Anesthesia
• Interventions: Other: nil intervention

• Registration Number: NCT05255432
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-11
• Study Start: 2022-06
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Member of staff trained in placing airways

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Exclusion Criteria

• Previous knowledge of the device

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	nil intervention	Selection of tasks
Group B	nil intervention	Selection of tasks

Primary Outcome Measures

Name	Time	Method
Performance of user against the predetermined standard	1 hour	The users will be marked against a standard set to look for problems