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

IntelligentUltrasound Limited58 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ultrasound Imaging of Anatomical Structures

Interventions

ScanNav Anatomy PNBDEVICE

AI-powered device that highlights anatomy of interest during ultrasound scans.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

UCH Education Centre

London, United Kingdom

Outcomes

Primary Outcomes

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)

Time frame: 8-10 weeks

Secondary Outcomes

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 frame: Time 0

Anatomy identification

Correct identification of anatomical structures on the block view \[Y/N\]

Time frame: Time 0 and 8-10 weeks

Participant confidence

Participant confidence in ultrasound scanning \[continuous scale; 0 (no confidence\] - 10 (total confidence)\]

Time frame: 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 frame: Time 0 and 8-10 weeks

Data from ClinicalTrials.gov

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