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

Intelligent Ultrasound

Status: Completed

Conditions: Ultrasound Imaging of Anatomical Structures

Treatments: Device: ScanNav Anatomy PNB

Study type: Observational

Funder types: Industry

Identifiers

NCT05583032

IU2022_AG_10

Details and patient eligibility

About

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

Full 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).

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

58 participants in 2 patient groups

ScanNav Anatomy PNB aided

Description:

Participants completing scans for regional anaesthesia with the aid of ScanNav Anatomy PNB.

Treatment:

Device: ScanNav Anatomy PNB

ScanNav Anatomy PNB unaided

Description:

Participants completing scans for regional anaesthesia without the aid of ScanNav Anatomy PNB.