Validity of Experts and ScanNav Anatomy PNB When Identifying Sono-anatomical Structures for Ultrasound-Guided Regional Anaesthesia

NCT04983771 | Completed

• 1 other identifier: R75449/RE001-1
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-centre, prospective, observational study, conducted under the auspices of the University of Oxford to evaluate ultrasound image analysis by human experts and an artificial intelligence device in the context of ultrasound-guided regional anaesthesia (UGRA).

Conditions

Ultrasound Imaging of Anatomical Structures

Outcome Measures

Primary Outcomes (2)

• Experts' variability

  Assess variability in identification of key anatomical structures on ultrasound by individual members of the expert panel

  2 years

• ScanNav anatomy PNB comparison

  Compare the identification of anatomical structures on ultrasound images by an artificial intelligence system to the combined assessment of a panel of experts

  2 years

Study Arms (1)

Expert in ultrasound-guided regional anaesthesia

At least 15 UGRA experts, member of a relevant professional society (e.g., RA-UK, ESRA, ASRA) and meeting at least 3 of the following criteria) will be recruited from centres in the UK. * Completed advanced training in UGRA or have \>10 years of independent practice in UGRA * Hold a qualification related to UGRA (e.g., EDRA, higher degree or equivalent) * Regularly delivers direct clinical care using UGRA, including for 'awake' surgery where indicated * Regularly teaches UGRA in the course of their clinical work, including advanced techniques (Plan B/C/D blocks) where indicated

Device: Annotate ultrasound scans

Interventions

Annotate ultrasound scans DEVICE

Each expert will be asked to hand-labelled anatomical structures on relevant ultrasound images

Expert in ultrasound-guided regional anaesthesia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least 15 UGRA experts will be recruited from seven centres in the UK.

You may qualify if:

• Member of a relevant professional society (e.g., RA-UK, ESRA, ASRA) and meets at least three of the following criteria:
• Completed advanced training in UGRA or have \>10 years of independent practice in UGRA
• Hold a qualification related to UGRA (e.g., EDRA, higher degree or equivalent)
• Regularly delivers direct clinical care using UGRA, including for 'awake' surgery where indicated
• Regularly teaches UGRA in the course of their clinical work, including advanced techniques (Plan B/C/D blocks) where indicated

You may not qualify if:

• none

Sponsors & Collaborators

• IntelligentUltrasound Limited: lead
• University of Oxford: collaborator

Study Sites (1)

Intelligent Ultrasound Limited

Cardiff, Wales, CF10 1DY, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: September 1, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: August 1, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)