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Completed

NCT Number: NCT05156099

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

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

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Key information

Conditions

Ultrasound Imaging of Anatomical Structures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intelligent Ultrasound Limited

Cardiff, Wales, CF10 1DY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 12 months

    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]

Secondary outcomes

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

    Time frame: 12 months

    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]

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

    Time frame: 12 months

    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)]

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

    Time frame: 12 months

    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]

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

    Time frame: 12 months

    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)]

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

    Time frame: 12 months

    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]

Sponsors and collaborators

Lead sponsor

IntelligentUltrasound Limited

Industry

Registry information

Official study 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

Acronym: PNB

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2021
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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