Use of Alexa as a Cognitive Aid for Emergency Front Of Neck Access (FONA)

NCT ID: NCT05635773

Last Updated: 2022-12-02

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

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-05-01

Brief Summary

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The aim of the study is to investigate whether a voice activated cognitive aid can improve performance in a simulated emergency front-of-neck access scenario. This skill is ideally practiced on an annual basis by anaesthetists in training, with a variety of usually low-fidelity simulation used.

The addition of the Alexa cognitive aid is a novel step with the aim of improving adherence to the recommended steps required to successfully complete the procedure. One arm of this study will be introduced to the Alexa checklist in advance of performing the procedure prior to crossover, whereas the second arm will not (subject to standard anaesthetic training).

Detailed Description

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Conditions

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Intubation; Difficult or Failed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomisation will be carried out using a randomization table made at www.randomizer.org to even/odd allocation numbers corresponding to 'Alexa first' vs 'No Alexa first' group with equal allocation between each arm. The randomisation sequence will be known only to the investigators issuing the initial grouping to the candidate, and allocations will be concealed from the video recording assessors and the statistical analysis team.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Assessors marking the recorded performances will be blinded as to which group the candidate had been allocated to in the first instance. The statistical analysis team will also be blinded to the allocation sequence.

Study Groups

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eFONA No Alexa

Arm randomised to performing the procedure without Alexa cognitive aid first

Group Type ACTIVE_COMPARATOR

Use of Alexa Visual Cognitive aid

Intervention Type DEVICE

The intervention is the use of of a cognitive aid to determine the efficacy of the aid in completing the steps correctly.

eFONA Alexa

Arm randomised to performing the procedure using Alexa cognitive aid first

Group Type EXPERIMENTAL

Use of Alexa Visual Cognitive aid

Intervention Type DEVICE

The intervention is the use of of a cognitive aid to determine the efficacy of the aid in completing the steps correctly.

Interventions

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Use of Alexa Visual Cognitive aid

The intervention is the use of of a cognitive aid to determine the efficacy of the aid in completing the steps correctly.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* CT1 to Consultant level Anaesthetists, who have completed the Initial Assessment of Competencies (IAC)

Exclusion Criteria

* Anaesthetists without the above criteria, refusal
Minimum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig Johnstone, MBChB

Role: PRINCIPAL_INVESTIGATOR

Guy's & St Thomas' NHS Trust

Locations

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Guy's & St Thomas' NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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gill Arbane

Role: CONTACT

+442071854462

Facility Contacts

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Craig Johnstone

Role: primary

Other Identifiers

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IRAS 266480

Identifier Type: -

Identifier Source: org_study_id

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