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

NCT05635773 | Unknown

• 1 other identifier: IRAS 266480
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (1)

• The number of critical steps missed.

  What critical steps were missed

  6 months

Secondary Outcomes (5)

• All critical steps completed

  6 months

• Hypoxic time (interval between SpO2 first <94% to recover >=94% - explicitly timed gradual decrease in saturations)

  6 months

• A measure of participant workload (e.g. NASA-TLX) as perceived and completed by the participant after each arm.

  6 months

• A measure of team working (e.g. ANTS score) for each individual procedure

  6 months

• A measure of participant's subjective experience (e.g. qualitative analysis of participant feedback on the device)

  6 months

Study Arms (2)

eFONA No Alexa

ACTIVE COMPARATOR

Arm randomised to performing the procedure without Alexa cognitive aid first

Device: Use of Alexa Visual Cognitive aid

eFONA Alexa

EXPERIMENTAL

Arm randomised to performing the procedure using Alexa cognitive aid first

Device: Use of Alexa Visual Cognitive aid

Interventions

Use of Alexa Visual Cognitive aid 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; eFONA No Alexa

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Anaesthetists without the above criteria, refusal

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's & St Thomas' NHS Trust

London, SE1 9RT, United Kingdom

RECRUITING

Study Officials

• Craig Johnstone, MBChB

  Guy's & St Thomas' NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gill Arbane

CONTACT

+442071854462; R&D@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: December 2, 2022
• Study Start: June 30, 2022
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-04

Locations

GB (1)