Ultrasound Imaging of Anatomical StructuresNCT05583032
An Evaluation of the Long-Term Impact of Assistive AI on Anaesthetists' Ultrasound Scanning for UGRA
An observational study of Ultrasound Imaging of Anatomical Structures, run by IntelligentUltrasound Limited at 1 site in United Kingdom.
Trial summary
A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia. 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?
- ScanNav Anatomy PNB
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2022to 30 Jul 2023
- 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: 70 participants will be recruited to represent the intended user population (anaesthetists qualified to perform UGRA, but non-experts in the field of regional anaesthesia). Potential study participants will be identified by approaching professional anaesthesia/anaesthetics societies, networks (e.g., Wales Regional Anaesthesia Group - South).
Who may be able to join
- Anaesthetist in Stage 1 of UK Anaesthesia Core/Specialty Training (CT 1-3)
- Able to comprehend and sign the Informed Consent prior to enrolment in the study
- Available to travel and attend the study day in person
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.
About this study
Official title: A Randomised Prospective Evaluation of the Long-Term Impact of Assistive Artificial Intelligence on Anaesthetists' Ultrasound Scanning for Regional Anaesthesia
A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia.
Read the detailed description
This is a randomised, blinded interventional prospective study which will be conducted and reported as per the Consolidated Standards of Reporting Trials - Artificial Intelligence (CONSORT-AI) guidance. The study end points have been defined prospectively, and data will be divided into two cohorts (with vs without ScanNav Anatomy PNB assistance). Participants will be asked to perform ultrasound (US) scanning on healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance, both with and without the device. The US scans will be recorded and blinded expert observers (without knowledge of whether ScanNav Anatomy PNB is in use) will also assess acquisition of an appropriate block view (panel of three experts, one viewing each scan as per the unblinded assessors). The initial assessment will be undertaken after a scanning tutorial and then repeated after 8-10 weeks (to assess longer-term impact of the device).
- Being tested
- ScanNav Anatomy PNB
- Keywords
- ScanNav, Anatomy PNB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScanNav Anatomy PNBDevice
AI-powered device that highlights anatomy of interest during ultrasound scans.
| Study group | Role | What they receive |
|---|---|---|
| ScanNav Anatomy PNB aided | Participants completing scans for regional anaesthesia with the aid of ScanNav Anatomy PNB. Receives: Device: ScanNav Anatomy PNB | |
| ScanNav Anatomy PNB unaided | Participants completing scans for regional anaesthesia without the aid of ScanNav Anatomy PNB. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block identification (long-term)
Identification of an appropriate block view by participant [blinded expert's opinion; Y/N] both with and without the use of ScanNav Anatomy PNB for ultrasound scanning (8 - 10 weeks after teaching)
Measured: 8-10 weeks
Secondary outcomes (4)
Block identification (immediate)
Identification of an appropriate block view by participant [blinded expert's opinion; Y/N] both with and without the use of ScanNav Anatomy PNB for ultrasound scanning (immediately after teaching)
Measured: Time 0
Anatomy identification
Correct identification of anatomical structures on the block view [Y/N]
Measured: Time 0 and 8-10 weeks
Participant confidence
Participant confidence in ultrasound scanning [continuous scale; 0 (no confidence] - 10 (total confidence)]
Measured: Time 0 and 8-10 weeks
Overall scan performance
Expert observer's assessment of the participant's overall ultrasound scanning performance [continuous scale; 0 (poor) - 10 (excellent)]
Measured: Time 0 and 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start24 Nov 2022
- Primary completion30 Jan 2023
- Study completion30 Jul 2023
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntelligentUltrasound Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Bowness, Dr, Principal investigator, Intelligent Ultrasound
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583032
- Sponsor's protocol ID
- IU2022_AG_10
- Status last verified
- Aug 2023
- First submitted
- 13 Oct 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kowa CY, Morecroft M, Macfarlane AJR, Burckett-St Laurent D, Pawa A, West S, Margetts S, Haslam N, Ashken T, Sebastian MP, Thottungal A, Womack J, Noble JA, Higham H, Bowness JS. Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia. BMJ Surg Interv Health Technol. 2024 Oct 16;6(1):e000264. doi: 10.1136/bmjsit-2024-000264. eCollection 2024.
PubMed 39430867
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Prospective Evaluation of the Long-Term Impact of Assistive Artificial Intelligence on Anaesthetists' Ultrasound Scanning for Regional Anaesthesia
- ClinicalTrials.gov ID
- NCT05583032
- Acronym / sponsor ID
- IU2022_AG_10
- Keywords
- ScanNav, Anatomy PNB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- IntelligentUltrasound LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 17 Oct 2022 (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.
A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia.
Detailed description
This is a randomised, blinded interventional prospective study which will be conducted and reported as per the Consolidated Standards of Reporting Trials - Artificial Intelligence (CONSORT-AI) guidance. The study end points have been defined prospectively, and data will be divided into two cohorts (with vs without ScanNav Anatomy PNB assistance). Participants will be asked to perform ultrasound (US) scanning on healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance, both with and without the device. The US scans will be recorded and blinded expert observers (without knowledge of whether ScanNav Anatomy PNB is in use) will also assess acquisition of an appropriate block view (panel of three experts, one viewing each scan as per the unblinded assessors). The initial assessment will be undertaken after a scanning tutorial and then repeated after 8-10 weeks (to assess longer-term impact of the device).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ScanNav Anatomy PNB aided | – | Device: ScanNav Anatomy PNBParticipants completing scans for regional anaesthesia with the aid of ScanNav Anatomy PNB. |
| ScanNav Anatomy PNB unaided | – | –Participants completing scans for regional anaesthesia without the aid of ScanNav Anatomy PNB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 70 participants will be recruited to represent the intended user population (anaesthetists qualified to perform UGRA, but non-experts in the field of regional anaesthesia). Potential study participants will be identified by approaching professional anaesthesia/anaesthetics societies, networks (e.g., Wales Regional Anaesthesia Group - South).
Key inclusion criteria (3 listed)
- Anaesthetist in Stage 1 of UK Anaesthesia Core/Specialty Training (CT 1-3)
- Able to comprehend and sign the Informed Consent prior to enrolment in the study
- Available to travel and attend the study day in person
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 |
|---|---|---|
| ScanNav Anatomy PNBAI-powered device that highlights anatomy of interest during ultrasound scans. | Device | ScanNav Anatomy PNB aided |
Primary outcome
Block identification (long-term)
Time frame: 8-10 weeks
Identification of an appropriate block view by participant [blinded expert's opinion; Y/N] both with and without the use of ScanNav Anatomy PNB for ultrasound scanning (8 - 10 weeks after teaching)
4 secondary outcomes
Block identification (immediate)
Time frame: Time 0
Anatomy identification
Time frame: Time 0 and 8-10 weeks
Participant confidence
Time frame: Time 0 and 8-10 weeks
Overall scan performance
Time frame: Time 0 and 8-10 weeks
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 14 Aug 2023.
- Derived from this study: PubMed 39430867Kowa CY, Morecroft M, Macfarlane AJR, Burckett-St Laurent D, Pawa A, West S, Margetts S, Haslam N, Ashken T, Sebastian MP, Thottungal A, Womack J, Noble JA, Higham H, Bowness JS. Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia. BMJ Surg Interv Health Technol. 2024 Oct 16;6(1):e000264. doi: 10.1136/bmjsit-2024-000264. eCollection 2024.
- Individual participant dataSharing planned: No
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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
Intelligent Ultrasound
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 3 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 14 Aug 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?
Block identification (long-term) (time frame: 8-10 weeks). 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 NCT05583032, 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 14 Aug 2023.