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

Completed

• Conditions: Ultrasound Imaging of Anatomical Structures
• Interventions: Device: ScanNav Anatomy PNB

• Registration Number: NCT05583032
• Lead Sponsor: IntelligentUltrasound Limited

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).

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Study Start: 2022-11-24
• Primary Completion: 2023-01-30
• Study Completion: 2023-07-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ScanNav Anatomy PNB aided	ScanNav Anatomy PNB	Participants completing scans for regional anaesthesia with the aid of ScanNav Anatomy PNB.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 \[continuous scale; 0 (poor) - 10 (excellent)\]
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)

Trial Locations

Locations (1)

UCH Education Centre; 🇬🇧 London, United Kingdom