Clinical Trials Directory

Trials / Completed

CompletedNCT05583032

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
58 (actual)
Sponsor
IntelligentUltrasound Limited · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEScanNav Anatomy PNBAI-powered device that highlights anatomy of interest during ultrasound scans.

Timeline

Start date
2022-11-24
Primary completion
2023-01-30
Completion
2023-07-30
First posted
2022-10-17
Last updated
2023-08-14

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05583032. Inclusion in this directory is not an endorsement.