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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms

  • Ultrasound Imaging of Anatomical Structures

NCT number NCT05583032
Study type Observational
Source IntelligentUltrasound Limited
Contact
Status Completed
Phase
Start date November 24, 2022
Completion date July 30, 2023

See also
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Completed NCT04918693 - A Study to Evaluate the Performance and Potential Benefits of an Assistive Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block - US V1.0 for Ultrasound-guided Regional Anesthesia
Completed NCT04906018 - A Study to Collect Imaging Data for the Validation of the Intelligent Ultrasound's ScanNav Anatomy Peripheral Nerve Block (PNB) - US v1.0
Completed NCT04830891 - A Volunteer Study to Collect Imaging Data for the Development and Validation of ScanNav Anatomy PNB
Completed NCT04277169 - A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide
Completed NCT05156099 - Clinical Performance Study: Evaluate Scanning & Interpretation Performance With & Without ScanNav Anatomy PNB
Completed NCT06375603 - Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software
Completed NCT04040179 - A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide
Completed NCT06025279 - Musculoskeletal System Ultrasound Examination Data Collection Study for the Development of an Artificial Intelligence Software