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

November 22, 2022 updated by: Guy's and St Thomas' NHS Foundation Trust

The Role of a Visual Alexa Enabled Visual Device in Aiding Performance in Emergency Front-of-Neck Access (eFONA-A) Within a Simulated 'Can't Intubate Can't Oxygenate' Scenario

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

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

Study Locations

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

23 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Anaesthetists without the above criteria, refusal

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: eFONA No Alexa
Arm randomised to performing the procedure without Alexa cognitive aid first
Device: 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.
Experimental: eFONA Alexa
Arm randomised to performing the procedure using Alexa cognitive aid first
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of critical steps missed.
Time Frame: 6 months
What critical steps were missed
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All critical steps completed
Time Frame: 6 months
What critical steps were completed
6 months
Hypoxic time (interval between SpO2 first <94% to recover >=94% - explicitly timed gradual decrease in saturations)
Time Frame: 6 months
What was the hypoxic time
6 months
A measure of participant workload (e.g. NASA-TLX) as perceived and completed by the participant after each arm.
Time Frame: 6 months
Workload time versus perceived time per participant
6 months
A measure of team working (e.g. ANTS score) for each individual procedure
Time Frame: 6 months
Actual measure per participant per procedure
6 months
A measure of participant's subjective experience (e.g. qualitative analysis of participant feedback on the device)
Time Frame: 6 months
Feedback from each participant about the device
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Craig Johnstone, MBChB, Guy's & St Thomas' NHS Trust

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 (Actual)

June 30, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS 266480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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