Summative Evaluation to Validate the LEAFix Device With Users (LEAFIXUser)
May 10, 2022 updated by: Liverpool University Hospitals NHS Foundation Trust
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
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Richard Ramsaran, MBChB
- Phone Number: 07709674876
- Email: richard.ramsaran@liverpoolft.nhs.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Practioners who perform airway placement
Description
Inclusion Criteria:
- Member of staff trained in placing airways
Exclusion Criteria:
- Previous knowledge of the device
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
Selection of tasks
|
Users observation using medical device on manakin, different scenarios per group
|
|
Group B
Selection of tasks
|
Users observation using medical device on manakin, different scenarios per group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance of user against the predetermined standard
Time Frame: 1 hour
|
The users will be marked against a standard set to look for problems
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2022
Primary Completion (ANTICIPATED)
August 1, 2022
Study Completion (ANTICIPATED)
September 1, 2022
Study Registration Dates
First Submitted
February 16, 2022
First Submitted That Met QC Criteria
February 16, 2022
First Posted (ACTUAL)
February 24, 2022
Study Record Updates
Last Update Posted (ACTUAL)
May 11, 2022
Last Update Submitted That Met QC Criteria
May 10, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- SP0920
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.