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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| James Bowness, Dr | OxSTaR, University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intelligent Ultrasound Limited | Cardiff | Wales | CF10 1DY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36088136 | Derived | 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. |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
|
| 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 |