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

  • STATUS
    Recruiting
  • End date
    Nov 23, 2023
  • participants needed
    70
  • sponsor
    IntelligentUltrasound Limited
Updated on 23 October 2022
Accepts healthy volunteers

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).

Details
Condition Ultrasound Imaging of Anatomical Structures
Treatment ScanNav Anatomy PNB
Clinical Study IdentifierNCT05583032
SponsorIntelligentUltrasound Limited
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Anaesthetist in Stage 1 of UK Anaesthesia Core/Specialty Training (CT 1-3)
Able to comprehend and sign the Informed Consent prior to enrolment in the study
Available to travel and attend the study day in person

Exclusion Criteria

Aged <18 years of age
Unwilling or unable to provide informed consent
Expert in UGRA (see definition above)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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