Clinical Performance Study: Evaluate Scanning & Interpretation Performance With & Without ScanNav Anatomy PNB
NCT ID: NCT05156099
Last Updated: 2023-03-28
Study Results
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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COMPLETED
21 participants
OBSERVATIONAL
2021-12-06
2022-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ScanNav Anatomy PNB unaided
The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance without the device.
Ultrasound Scanning
The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance.
Ultrasound Scanning - 2 months later
The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance.
ScanNav Anatomy PNB-aided
The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance with the device.
Ultrasound Scanning
The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance.
Ultrasound Scanning - 2 months later
The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance.
Interventions
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Ultrasound Scanning
The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance.
Ultrasound Scanning - 2 months later
The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance.
Eligibility Criteria
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Inclusion Criteria
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 in Cardiff, UK
4. Medical professional (currently practicing anaesthetist or similar clinician) who is qualified to perform UGRA
5. Do not self-identify as an expert in the field of UGRA:
1. Has not completed advanced training or hold a qualification (e.g., EDRA, MSc, MD, PhD) related to UGRA
2. Does not regularly deliver anaesthesia for 'awake' surgery (excluding central neuraxial techniques)
3. Does not teach on formal RA courses
Exclusion Criteria
2. Unwilling or unable to provide informed consent
3. Expert in UGRA (see definition above)
18 Years
ALL
Yes
Sponsors
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IntelligentUltrasound Limited
INDUSTRY
Responsible Party
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Principal Investigators
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James Bowness, Dr
Role: PRINCIPAL_INVESTIGATOR
OxSTaR, University of Oxford
Locations
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Intelligent Ultrasound Limited
Cardiff, Wales, United Kingdom
Countries
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References
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Bowness JS, Macfarlane AJR, Burckett-St Laurent D, Harris C, Margetts S, Morecroft M, Phillips D, Rees T, Sleep N, Vasalauskaite A, West S, Noble JA, Higham H. Evaluation of the impact of assistive artificial intelligence on ultrasound scanning for regional anaesthesia. Br J Anaesth. 2023 Feb;130(2):226-233. doi: 10.1016/j.bja.2022.07.049. Epub 2022 Sep 8.
Other Identifiers
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IU2021_AG_06
Identifier Type: -
Identifier Source: org_study_id
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