Intubation; Difficult or FailedFONA-ANCT05635773
Use of Alexa as a Cognitive Aid for Emergency Front Of Neck Access (FONA)
A study testing Use of Alexa Visual Cognitive aid in people with Intubation; Difficult or Failed, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 23 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Use of Alexa Visual Cognitive aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CT1 to Consultant level Anaesthetists, who have completed the Initial Assessment of Competencies (IAC)
Who cannot join
- Anaesthetists without the above criteria, refusal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas' NHS Trust
London, SE1 9RT
Craig Johnstone, craig.johnstone@gstt.nhs.uk
About this study
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
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
- Being tested
- Use of Alexa Visual Cognitive aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Alexa Visual Cognitive aidDevice
The intervention is the use of of a cognitive aid to determine the efficacy of the aid in completing the steps correctly.
| Study group | Role | What they receive |
|---|---|---|
| eFONA No Alexa | Active comparator | Arm randomised to performing the procedure without Alexa cognitive aid first Receives: Device: Use of Alexa Visual Cognitive aid |
| eFONA Alexa | Experimental | Arm randomised to performing the procedure using Alexa cognitive aid first Receives: Device: Use of Alexa Visual Cognitive aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of critical steps missed.
What critical steps were missed
Measured: 6 months
Secondary outcomes (5)
All critical steps completed
What critical steps were completed
Measured: 6 months
Hypoxic time (interval between SpO2 first <94% to recover >=94% - explicitly timed gradual decrease in saturations)
What was the hypoxic time
Measured: 6 months
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
Measured: 6 months
A measure of team working (e.g. ANTS score) for each individual procedure
Actual measure per participant per procedure
Measured: 6 months
A measure of participant's subjective experience (e.g. qualitative analysis of participant feedback on the device)
Feedback from each participant about the device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start30 Jun 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Johnstone, MBChB, Principal investigator, Guy's & St Thomas' NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635773
- Sponsor's protocol ID
- IRAS 266480
- Acronym
- FONA-A
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05635773
- Acronym / sponsor ID
- FONA-A / IRAS 266480
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| eFONA No Alexa | Active comparator | Device: Use of Alexa Visual Cognitive aidArm randomised to performing the procedure without Alexa cognitive aid first |
| eFONA Alexa | Experimental | Device: Use of Alexa Visual Cognitive aidArm randomised to performing the procedure using Alexa cognitive aid first |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CT1 to Consultant level Anaesthetists, who have completed the Initial Assessment of Competencies (IAC)
Key exclusion criteria (1 listed)
- Anaesthetists without the above criteria, refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Alexa Visual Cognitive aidThe intervention is the use of of a cognitive aid to determine the efficacy of the aid in completing the steps correctly. | Device | eFONA Alexa, eFONA No Alexa |
Primary outcome
The number of critical steps missed.
Time frame: 6 months
What critical steps were missed
5 secondary outcomes
All critical steps completed
Time frame: 6 months
Hypoxic time (interval between SpO2 first <94% to recover >=94% - explicitly timed gradual decrease in saturations)
Time frame: 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
A measure of team working (e.g. ANTS score) for each individual procedure
Time frame: 6 months
A measure of participant's subjective experience (e.g. qualitative analysis of participant feedback on the device)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Johnstone, MBChB principal investigator
Guy's & St Thomas' NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Alexa Visual Cognitive aid in people with Intubation; Difficult or Failed, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gill Arbane (+442071854462, R&D@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of critical steps missed. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.