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

A Pilot Study to Evaluate Anaesthetists' Ultrasound Scanning & Interpretation Performance for Ultrasound-guided Regional Anaesthesia - With & Without the Assistance of an Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block

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

Study Overview

• Status: Completed
• Conditions: Ultrasound Imaging of Anatomical Structures
• Intervention / Treatment: Device: Ultrasound Scanning; Device: Ultrasound Scanning - 2 months later

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

• Study Contact: Name: Steve Margetts; Phone Number: 00442920756534; Email: Steve.Margetts@intelligentultrasound.com
• Study Contact Backup: Name: Asta Vasalauskaite; Phone Number: 00442920756534; Email: Asta.Vasalauskaite@intelligentultrasound.com

Study Locations

• United Kingdom
  • Wales
    • Cardiff, Wales, United Kingdom, CF10 1DY
      • Intelligent Ultrasound Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; 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.
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; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required to scan (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) Time in seconds required for participant to scan [to obtain a satisfactory view of an appropriate block site, in the participant's opinion]	12 months
confidence in identifying an 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) Participant confidence in identifying an appropriate block site [0 (no confidence] - 10 (total confidence)]	12 months
Correct identification of key structures (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 key structures (including safety critical) at that block site by participant [expert observer's opinion; Y/N]	12 months
Expert observer's assessment (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) Expert observer's assessment of the participant's total scanning performance [0 (poor) - 10 (excellent)]	12 months
Quantify the change in incorrect identification of safety critical anatomical structures (at initial assessment and 2 months later)	Quantify the change in incorrect identification of safety critical anatomical structures associated with ScanNav Anatomy PNB during UGRA scanning (for block regions of the upper limb, trunk and lower limb), False positive/negative identification rates for blood vessels, nerves, pleura and peritoneum by participant [expert observer's opinion of participant judgement; Y/N]	12 months

Collaborators and Investigators

• Sponsor: IntelligentUltrasound Limited

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IU2021_AG_06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No