Ultrasound Imaging of Anatomical Structures
Conditions
Keywords
ScanNav, Anatomy PNB
Brief summary
A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia.
Detailed description
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).
Interventions
DEVICEScanNav Anatomy PNB
AI-powered device that highlights anatomy of interest during ultrasound scans.
Sponsors
IntelligentUltrasound Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Anaesthetist in Stage 1 of UK Anaesthesia Core/Specialty Training (CT 1-3) 2. Able to comprehend and sign the Informed Consent prior to enrolment in the study 3. Available to travel and attend the study day in person
Exclusion criteria
1. Aged \<18 years of age 2. Unwilling or unable to provide informed consent 3. Expert in UGRA (see definition above)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Block identification (long-term) | 8-10 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block identification (immediate) | Time 0 | 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) |
| Anatomy identification | Time 0 and 8-10 weeks | Correct identification of anatomical structures on the block view \[Y/N\] |
| Participant confidence | Time 0 and 8-10 weeks | Participant confidence in ultrasound scanning \[continuous scale; 0 (no confidence\] - 10 (total confidence)\] |
| Overall scan performance | Time 0 and 8-10 weeks | Expert observer's assessment of the participant's overall ultrasound scanning performance \[continuous scale; 0 (poor) - 10 (excellent)\] |
Countries
United Kingdom
Outcome results
None listed