Clinical trial NCT05156099: Clinical Performance Study: Evaluate Scanning & Interpretation Performance With & Without ScanNav Anatomy PNB
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Imaging of Anatomical Structures
Lead sponsor: IntelligentUltrasound Limited
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Correct identification of appropriate block site (at initial assessment and 2 months later)
timeFrame: 12 months
Secondary outcomes:
measure: Time required to scan (at initial assessment and 2 months later)
timeFrame: 12 months
measure: confidence in identifying an appropriate block site (at initial assessment and 2 months later)
timeFrame: 12 months
measure: Correct identification of key structures (at initial assessment and 2 months later)
timeFrame: 12 months
measure: Expert observer's assessment (at initial assessment and 2 months later)
timeFrame: 12 months
measure: Quantify the change in incorrect identification of safety critical anatomical structures (at initial assessment and 2 months later)
timeFrame: 12 months
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Intelligent Ultrasound Limited
state: Wales
Study officials:
affiliation: OxSTaR, University of Oxford
name: James Bowness, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.