This is a single-centre, randomised, interventional prospective cohort study to be undertaken at offices of Intelligent Ultrasound Limited in Cardiff, United Kingdom.
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
21
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.
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.
Intelligent Ultrasound Limited
Cardiff, Wales, United Kingdom
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 \[expert observer's opinion; Y/N\]
Time frame: 12 months
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 \[to obtain a satisfactory view of an appropriate block site, in the participant's opinion\]
Time frame: 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)\]
Time frame: 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 \[expert observer's opinion; Y/N\]
Time frame: 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 \[0 (poor) - 10 (excellent)\]
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Time frame: 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 \[expert observer's opinion of participant judgement; Y/N\]
Time frame: 12 months