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

Ultrasound Imaging of Anatomical Structures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05583032
• Other study ID #: IU2022_AG_10
• Status: Completed
• Start date: November 24, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: August 2023
• Source: IntelligentUltrasound Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ultrasound Imaging of Anatomical Structures

Intervention

Device:
• ScanNav Anatomy PNB
AI-powered device that highlights anatomy of interest during ultrasound scans.

Locations

Country	Name	City	State
United Kingdom	UCH Education Centre	London

Sponsors (1)

Lead Sponsor	Collaborator
IntelligentUltrasound Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Anatomy identification	Correct identification of anatomical structures on the block view [Y/N]	Time 0 and 8-10 weeks
Secondary	Participant confidence	Participant confidence in ultrasound scanning [continuous scale; 0 (no confidence] - 10 (total confidence)]	Time 0 and 8-10 weeks
Secondary	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