Ultrasound Imaging of Anatomical StructuresPNBNCT05156099
Clinical Performance Study: Evaluate Scanning & Interpretation Performance With & Without ScanNav Anatomy PNB
An observational study of Ultrasound Imaging of Anatomical Structures, run by IntelligentUltrasound Limited at 1 site in United Kingdom.
Trial summary
This is a single-centre, randomised, interventional prospective cohort study to be undertaken at offices of Intelligent Ultrasound Limited in Cardiff, United Kingdom. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Imaging of Anatomical Structures
- What is being tested?
- Ultrasound Scanning and Ultrasound Scanning - 2 months later
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2021to 8 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Aged <18 years of age
- Unwilling or unable to provide informed consent
- Expert in UGRA (see definition above)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Intelligent Ultrasound Limited
Cardiff, Wales, CF10 1DY
About this study
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
This is a single-centre, randomised, interventional prospective cohort study to be undertaken at offices of Intelligent Ultrasound Limited in Cardiff, United Kingdom.
Read the 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.
- Being tested
- Ultrasound Scanning, Ultrasound Scanning - 2 months later
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ScanningDevice
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 laterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound Scanning; Device: Ultrasound Scanning - 2 months later | |
| 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. Receives: Device: Ultrasound Scanning; Device: Ultrasound Scanning - 2 months later |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 12 months
Secondary outcomes (5)
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]
Measured: 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)]
Measured: 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]
Measured: 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)]
Measured: 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]
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start6 Dec 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Imaging of Anatomical StructuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntelligentUltrasound Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Bowness, Dr, Principal investigator, OxSTaR, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156099
- Sponsor's protocol ID
- IU2021_AG_06
- Acronym
- PNB
- Status last verified
- Mar 2023
- First submitted
- 1 Dec 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36088136
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05156099
- Acronym / sponsor ID
- PNB / IU2021_AG_06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- IntelligentUltrasound LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ScanNav Anatomy PNB unaided | – | Device: Ultrasound Scanning, Device: Ultrasound Scanning - 2 months laterThe 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 | – | Device: Ultrasound Scanning, Device: Ultrasound Scanning - 2 months laterThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- Aged <18 years of age
- Unwilling or unable to provide informed consent
- Expert in UGRA (see definition above)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ScanningThe 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 | ScanNav Anatomy PNB unaided, ScanNav Anatomy PNB-aided |
| Ultrasound Scanning - 2 months laterThe 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 | ScanNav Anatomy PNB unaided, ScanNav Anatomy PNB-aided |
Primary outcome
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]
5 secondary outcomes
Time required to scan (at initial assessment and 2 months later)
Time frame: 12 months
confidence in identifying an appropriate block site (at initial assessment and 2 months later)
Time frame: 12 months
Correct identification of key structures (at initial assessment and 2 months later)
Time frame: 12 months
Expert observer's assessment (at initial assessment and 2 months later)
Time frame: 12 months
Quantify the change in incorrect identification of safety critical anatomical structures (at initial assessment and 2 months later)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 36088136Bowness 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Bowness, Dr principal investigator
OxSTaR, University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Imaging of Anatomical Structures, run by IntelligentUltrasound Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct identification of appropriate block site (at initial assessment and 2 months later) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05156099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.