An Evaluation of the Long-Term Impact of Assistive AI on Anaesthetists' Ultrasound Scanning for UGRA

Study Overview
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Brief Summary
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A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia.

Detailed Description
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This is a randomised, blinded interventional prospective study which will be conducted and reported as per the Consolidated Standards of Reporting Trials - Artificial Intelligence (CONSORT-AI) guidance. The study end points have been defined prospectively, and data will be divided into two cohorts (with vs without ScanNav Anatomy PNB assistance). Participants will be asked to perform ultrasound (US) scanning on healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance, both with and without the device. The US scans will be recorded and blinded expert observers (without knowledge of whether ScanNav Anatomy PNB is in use) will also assess acquisition of an appropriate block view (panel of three experts, one viewing each scan as per the unblinded assessors). The initial assessment will be undertaken after a scanning tutorial and then repeated after 8-10 weeks (to assess longer-term impact of the device).

Official Title
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A Randomised Prospective Evaluation of the Long-Term Impact of Assistive Artificial Intelligence on Anaesthetists' Ultrasound Scanning for Regional Anaesthesia

Conditions
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Ultrasound Imaging of Anatomical Structures

Intervention / Treatment
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* Device: ScanNav Anatomy PNB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anaesthetist in Stage 1 of UK Anaesthesia Core/Specialty Training (CT 1-3) Able to comprehend and sign the Informed Consent prior to enrolment in the study Available to travel and attend the study day in person Exclusion Criteria: Aged <18 years of age Unwilling or unable to provide informed consent Expert in UGRA (see definition above)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ScanNav Anatomy PNB aided<br>Participants completing scans for regional anaesthesia with the aid of ScanNav Anatomy PNB. | Device: ScanNav Anatomy PNB<br>* AI-powered device that highlights anatomy of interest during ultrasound scans.<br>|
| ScanNav Anatomy PNB unaided<br>Participants completing scans for regional anaesthesia without the aid of ScanNav Anatomy PNB. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block identification (long-term) | Identification of an appropriate block view by participant [blinded expert's opinion; Y/N] both with and without the use of ScanNav Anatomy PNB for ultrasound scanning (8 - 10 weeks after teaching) | 8-10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block identification (immediate) | Identification of an appropriate block view by participant [blinded expert's opinion; Y/N] both with and without the use of ScanNav Anatomy PNB for ultrasound scanning (immediately after teaching) | Time 0 | 
| Anatomy identification | Correct identification of anatomical structures on the block view [Y/N] | Time 0 and 8-10 weeks | 
| Participant confidence | Participant confidence in ultrasound scanning [continuous scale; 0 (no confidence] - 10 (total confidence)] | Time 0 and 8-10 weeks | 
| Overall scan performance | Expert observer's assessment of the participant's overall ultrasound scanning performance [continuous scale; 0 (poor) - 10 (excellent)] | Time 0 and 8-10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ScanNav, Anatomy PNB