Summative Evaluation to Validate the LEAFix Device With Users

NCT ID: NCT05255432

Last Updated: 2022-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Selection of tasks

nil intervention

Intervention Type OTHER

Users observation using medical device on manakin, different scenarios per group

Group B

Selection of tasks

nil intervention

Intervention Type OTHER

Users observation using medical device on manakin, different scenarios per group

Interventions

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nil intervention

Users observation using medical device on manakin, different scenarios per group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Member of staff trained in placing airways

Exclusion Criteria

* Previous knowledge of the device
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Richard Ramsaran, MBChB

Role: CONTACT

07709674876

Other Identifiers

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SP0920

Identifier Type: -

Identifier Source: org_study_id

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