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NCT05255432 Clinical Trial

Summative Evaluation to Validate the LEAFix Device With Users

Anesthesia Clinical Trial

— LEAFIXUser  

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05255432
Other study ID # SP0920
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2022
Est. completion date September 2022

Study information
Verified date May 2022
Source Liverpool University Hospitals NHS Foundation Trust
Contact Richard Ramsaran, MBChB
Phone 07709674876
Email richard.ramsaran@liverpoolft.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 32
Est. completion date September 2022
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Member of staff trained in placing airways Exclusion Criteria: - Previous knowledge of the device

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• nil intervention
Users observation using medical device on manakin, different scenarios per group

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Liverpool University Hospitals NHS Foundation Trust

Outcome
Type Measure Description Time frame Safety issue
Primary Performance of user against the predetermined standard The users will be marked against a standard set to look for problems 1 hour
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