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Completed

NCT Number: NCT05583032

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCH Education Centre

London, NW1 2PG, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ScanNav Anatomy PNB

Device

AI-powered device that highlights anatomy of interest during ultrasound scans.

Primary outcomes

  1. Block identification (long-term)

    Time frame: 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 outcomes

  1. Block identification (immediate)

    Time frame: 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)

  2. Anatomy identification

    Time frame: Time 0 and 8-10 weeks

    Correct identification of anatomical structures on the block view [Y/N]

  3. Participant confidence

    Time frame: Time 0 and 8-10 weeks

    Participant confidence in ultrasound scanning [continuous scale; 0 (no confidence] - 10 (total confidence)]

  4. Overall scan performance

    Time frame: Time 0 and 8-10 weeks

    Expert observer's assessment of the participant's overall ultrasound scanning performance [continuous scale; 0 (poor) - 10 (excellent)]

Sponsors and collaborators

Lead sponsor

IntelligentUltrasound Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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