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

Primary Purpose

Intubation; Difficult or Failed

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Use of Alexa Visual Cognitive aid
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Intubation; Difficult or Failed

Eligibility Criteria

23 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: CT1 to Consultant level Anaesthetists, who have completed the Initial Assessment of Competencies (IAC) Exclusion Criteria: Anaesthetists without the above criteria, refusal

Sites / Locations

  • Guy's & St Thomas' NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

eFONA No Alexa

eFONA Alexa

Arm Description

Arm randomised to performing the procedure without Alexa cognitive aid first

Arm randomised to performing the procedure using Alexa cognitive aid first

Outcomes

Primary Outcome Measures

The number of critical steps missed.
What critical steps were missed

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2022
Last Updated
November 22, 2022
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05635773
Brief Title
Use of Alexa as a Cognitive Aid for Emergency Front Of Neck Access (FONA)
Acronym
FONA-A
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation; Difficult or Failed

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eFONA No Alexa
Arm Type
Active Comparator
Arm Description
Arm randomised to performing the procedure without Alexa cognitive aid first
Arm Title
eFONA Alexa
Arm Type
Experimental
Arm Description
Arm randomised to performing the procedure using Alexa cognitive aid first
Intervention Type
Device
Intervention Name(s)
Use of Alexa Visual Cognitive aid
Intervention Description
The intervention is the use of of a cognitive aid to determine the efficacy of the aid in completing the steps correctly.
Primary Outcome Measure Information:
Title
The number of critical steps missed.
Description
What critical steps were missed
Time Frame
6 months
Secondary Outcome Measure Information:
Title
All critical steps completed
Description
What critical steps were completed
Time Frame
6 months
Title
Hypoxic time (interval between SpO2 first <94% to recover >=94% - explicitly timed gradual decrease in saturations)
Description
What was the hypoxic time
Time Frame
6 months
Title
A measure of participant workload (e.g. NASA-TLX) as perceived and completed by the participant after each arm.
Description
Workload time versus perceived time per participant
Time Frame
6 months
Title
A measure of team working (e.g. ANTS score) for each individual procedure
Description
Actual measure per participant per procedure
Time Frame
6 months
Title
A measure of participant's subjective experience (e.g. qualitative analysis of participant feedback on the device)
Description
Feedback from each participant about the device
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: CT1 to Consultant level Anaesthetists, who have completed the Initial Assessment of Competencies (IAC) Exclusion Criteria: Anaesthetists without the above criteria, refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gill Arbane
Phone
+442071854462
Email
R&D@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Johnstone, MBChB
Organizational Affiliation
Guy's & St Thomas' NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's & St Thomas' NHS Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Johnstone
Email
craig.johnstone@gstt.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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