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

NCT05156099 | Completed

• 1 other identifier: IU2021_AG_06
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ultrasound Imaging of Anatomical Structures

Outcome Measures

Primary Outcomes (1)

• Correct identification of appropriate block site (at initial assessment and 2 months later)

  Quantify the performance change associated with ScanNav Anatomy PNB during UGRA scanning: (for block regions of the upper limb, trunk, and lower limb). Correct identification of appropriate block site by participant \[expert observer's opinion; Y/N\]

  12 months

Secondary Outcomes (5)

• Time required to scan (at initial assessment and 2 months later)

  12 months

• confidence in identifying an appropriate block site (at initial assessment and 2 months later)

  12 months

• Correct identification of key structures (at initial assessment and 2 months later)

  12 months

• Expert observer's assessment (at initial assessment and 2 months later)

  12 months

• Quantify the change in incorrect identification of safety critical anatomical structures (at initial assessment and 2 months later)

  12 months

Study Arms (2)

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.

Device: Ultrasound Scanning; Device: Ultrasound Scanning - 2 months later

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.

Device: Ultrasound Scanning; Device: Ultrasound Scanning - 2 months later

Interventions

Ultrasound Scanning 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 unaided; ScanNav Anatomy PNB-aided

Ultrasound Scanning - 2 months later 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 unaided; ScanNav Anatomy PNB-aided

Eligibility Criteria

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

Study Population

24 participants will be recruited to represent the intended user population (anaesthetists qualified to perform UGRA, but non-experts in the field of regional anaesthesia), with an approximate 50/50 split between consultants and trainees. Potential study participants will be identified by approaching professional anaesthesia/anaesthetics societies, networks (e.g., Wales Regional Anaesthesia Group - South). Study participants will be required to attend one of the study assessment days at Intelligent Ultrasound head office in Cardiff, UK.

You may qualify if:

• Male or female, at least 18 years of age
• Able to comprehend and sign the Informed Consent prior to enrolment in the study
• Available to travel and attend the study day in person in Cardiff, UK
• Medical professional (currently practicing anaesthetist or similar clinician) who is qualified to perform UGRA
• Do not self-identify as an expert in the field of UGRA:
• Has not completed advanced training or hold a qualification (e.g., EDRA, MSc, MD, PhD) related to UGRA
• Does not regularly deliver anaesthesia for 'awake' surgery (excluding central neuraxial techniques)
• Does not teach on formal RA courses

You may not qualify if:

• Aged \<18 years of age
• Unwilling or unable to provide informed consent
• Expert in UGRA (see definition above)

Sponsors & Collaborators

• IntelligentUltrasound Limited: lead

Study Sites (1)

Intelligent Ultrasound Limited

Cardiff, Wales, CF10 1DY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36088136 DERIVED

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• James Bowness, Dr

  OxSTaR, University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: December 6, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)