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

Sponsor
IntelligentUltrasound Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05583032
Collaborator
(none)
70
1
2
12
5.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: ScanNav Anatomy PNB
N/A

Detailed 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

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Each participant will perform ultrasound scans with and without the device.Each participant will perform ultrasound scans with and without the device.
Masking:
None (Open Label)
Masking Description:
A proportion of the outcome assessors will be blinded.
Primary Purpose:
Other
Official Title:
A Randomised Prospective Evaluation of the Long-Term Impact of Assistive Artificial Intelligence on Anaesthetists' Ultrasound Scanning for Regional Anaesthesia
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: With Anatomy PNB

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

Device: ScanNav Anatomy PNB
AI-powered device that highlights anatomy of interest during ultrasound scans.

No Intervention: Without Anatomy PNB

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

Outcome Measures

Primary Outcome Measures

  1. Block identification (long-term) [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 Outcome Measures

  1. Block identification (immediate) [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 0 and 8-10 weeks]

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

  3. Participant confidence [Time 0 and 8-10 weeks]

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

  4. Overall scan performance [Time 0 and 8-10 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCH Education Centre London United Kingdom NW1 2PG

Sponsors and Collaborators

  • IntelligentUltrasound Limited

Investigators

  • Principal Investigator: James Bowness, Dr, Intelligent Ultrasound

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IntelligentUltrasound Limited
ClinicalTrials.gov Identifier:
NCT05583032
Other Study ID Numbers:
  • IU2022_AG_10
First Posted:
Oct 17, 2022
Last Update Posted:
Oct 17, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by IntelligentUltrasound Limited

Study Results

No Results Posted as of Oct 17, 2022