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

Intubation; Difficult or Failed Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635773
• Other study ID #: IRAS 266480
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: gill Arbane
• Phone: +442071854462
• Email: R&D[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Anaesthetists without the above criteria, refusal

Related Conditions & MeSH terms

• Emergencies
• Intubation; Difficult or Failed

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of critical steps missed.	What critical steps were missed	6 months
Secondary	All critical steps completed	What critical steps were completed	6 months
Secondary	Hypoxic time (interval between SpO2 first <94% to recover >=94% - explicitly timed gradual decrease in saturations)	What was the hypoxic time	6 months
Secondary	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	6 months
Secondary	A measure of team working (e.g. ANTS score) for each individual procedure	Actual measure per participant per procedure	6 months
Secondary	A measure of participant's subjective experience (e.g. qualitative analysis of participant feedback on the device)	Feedback from each participant about the device	6 months