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

NCT ID: NCT05583032

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-24

Study Completion Date

2023-07-30

Brief Summary

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

Detailed Description

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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

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Ultrasound Imaging of Anatomical Structures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ScanNav Anatomy PNB aided

Participants completing scans for regional anaesthesia with the aid of ScanNav Anatomy PNB.

ScanNav Anatomy PNB

Intervention Type DEVICE

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

ScanNav Anatomy PNB unaided

Participants completing scans for regional anaesthesia without the aid of ScanNav Anatomy PNB.

No interventions assigned to this group

Interventions

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ScanNav Anatomy PNB

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IntelligentUltrasound Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Bowness, Dr

Role: PRINCIPAL_INVESTIGATOR

Intelligent Ultrasound

Locations

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UCH Education Centre

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Kowa CY, Morecroft M, Macfarlane AJR, Burckett-St Laurent D, Pawa A, West S, Margetts S, Haslam N, Ashken T, Sebastian MP, Thottungal A, Womack J, Noble JA, Higham H, Bowness JS. Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia. BMJ Surg Interv Health Technol. 2024 Oct 16;6(1):e000264. doi: 10.1136/bmjsit-2024-000264. eCollection 2024.

Reference Type DERIVED
PMID: 39430867 (View on PubMed)

Other Identifiers

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IU2022_AG_10

Identifier Type: -

Identifier Source: org_study_id

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