Clinical Performance Study: Evaluate Scanning & Interpretation Performance With & Without ScanNav Anatomy PNB

NCT ID: NCT05156099

Last Updated: 2023-03-28

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

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-06

Study Completion Date

2022-12-08

Brief Summary

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This is a single-centre, randomised, interventional prospective cohort study to be undertaken at offices of Intelligent Ultrasound Limited in Cardiff, United Kingdom.

Detailed Description

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Current National Institute for Health and Care Excellence (NICE) guidance (NICE, 2009) supports the use of ultrasound-guidance for regional anaesthesia (UGRA) procedures as a consensus of clinical opinion agrees that nerve blocks are more successful and safer with ultrasound (US) guidance. Despite this, UGRA remains a difficult technique to master. This study will be used to determine whether ScanNav Anatomy PNB can support the performance of non-expert anaesthetist in UGRA scanning by highlighting key anatomical structures on the US image in real time.

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 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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female, at least 18 years of age
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

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

OxSTaR, University of Oxford

Locations

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Intelligent Ultrasound Limited

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 36088136 (View on PubMed)

Other Identifiers

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IU2021_AG_06

Identifier Type: -

Identifier Source: org_study_id

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