Ultrasound Imaging of Anatomical StructuresNCT04918693
A Study to Evaluate the Performance and Potential Benefits of an Assistive Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block - US V1.0 for Ultrasound-guided Regional Anesthesia
An observational study of Ultrasound Imaging of Anatomical Structures, run by IntelligentUltrasound Limited at 1 site in United States.
Trial summary
This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to provide data on the clinical performance of ScanNav Anatomy PNB for identification of anatomical structures during UGRA scanning, in particular: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Imaging of Anatomical Structures
- What is being tested?
- Ultrasound scanning
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2021to 30 Nov 2021
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants All participants must be anesthesiologists who are competent to perform UGRA independently. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified and licensed Medical Doctor. Trainees All trainees must be healthcare practitioners who are licensed to perform UGRA. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified health practitioner. Models 4 models will be selected carefully based on their BMI inclusion criteria.
Participant Inclusion criteria
- Completed advanced training (e.g., fellowship) in or hold a qualification related to UGRA
- Regularly delivers direct clinical care using UGRA, including for 'awake' surgery where indicated
- Member of a relevant professional society (e.g., ASA, ASRA, ESRA, RA-UK)
- Regularly teach UGRA in the course of their clinical work, including advanced techniques where indicated
Participant exclusion criteria
- Unwilling or unable to provide informed consent.
- Involved in development of the ScanNav Anatomy PNB device.
Trainee Inclusion criteria
- U.S. board-eligible/board-certified health practitioner who holds a qualification licensing to perform UGRA
- NOT capable or confident of independent UGRA practice
Trainee exclusion criteria
- Unwilling or unable to provide informed consent.
- Involved in development of the ScanNav Anatomy PNB device.
Models 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.
- To fit either BMI category: BMI <30 OR BMI >=30
Model Exclusion Criteria
- Aged <18 years of age or over 60 years or age
- Unwilling or unable to provide informed consent.
- BMI> 39 kg/m2
- Known pathology of the area to be scanned.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to provide data on the clinical performance of ScanNav Anatomy PNB for identification of anatomical structures during UGRA scanning, in particular:
- Assess the benefits of the device to intended users when supervising a trainee who is performing UGRA scanning.
- Assess the benefits of the device when intended users perform UGRA scanning.
- Assess risk mitigation by the intended users when performing UGRA scanning.
Read the detailed description
Background:
The American Society of Regional Anesthesia and Pain Medicine (ASRA) has published evidence-based assessment of ultrasound-guided regional anesthesia (Neal et al., 2010) concluding that ultrasound guidance is superior or equal to other non-ultrasound nerve localization techniques. A subsequent publication from ASRA (Neal et al., 2016), has strengthened their position of ultrasound guidance being superior than other methods, including for the reduction of local anesthetic systemic toxicity. However, ultrasound-guided regional anesthesia (UGRA) is a difficult technique to master. A key activity of UGRA is ultrasound image interpretation (Sites et al., 2009) which ScanNav Anatomy PNB is designed to support.
Methodology:
15 participants (anesthesiologists capable of independently performing UGRA) will be recruited to evaluate the performance and benefit of ScanNav Anatomy PNB device in person, by scanning 2 healthy models (n=1 BMI<30, n=1 BMI>=30 kg/m2).
The device performance and benefits will be ascertained once the scanning session for each block is complete by use of a structured questionnaire.
- Participants will be asked to scan a model with and without the use of ScanNav Anatomy PNB. The order of with/without the device will be randomized between participants.
- Participants will also be asked to supervise a trainee (another healthcare professional qualified to perform the UGRA procedure under supervision) while they are scanning models with and without ScanNav Anatomy PNB aid. The participant will always use the device first before supervising the trainee.
- The above will be performed on 2 models from different BMI categories (n=1 BMI<30, n=1 BMI>=30 kg/m2; total scans n=16).
- The order of models will be randomized between participants.
- All 9 supported regions will be evaluated; each region will be scanned/evaluated at least 3 times.
Data collection
- Participants and trainees will be asked to complete a structured questionnaire to assess the device performance and clinical benefits at the end of scanning for the block.
Data analysis:
- Data will be aggregated and evaluated on safety critical structure type basis.
- Quantitative data obtained from the participants will be presented as frequencies and expressed as percent of total or as mean ± s.d. where appropriate.
The collected data and overall performance and benefits of ScanNav Anatomy PNB will be evaluated and summarized by presence and absence of ScanNav Anatomy PNB assistance, trainee and stratified by low/high BMI model.
Independent expert evaluation
- The scans be recorded during the study sessions. These scans will be post processed to short clips (10 seconds prior to obtaining optimum view) and sent for evaluation to an independent expert panel.
- The expert panel will be asked to evaluate the scans and the ScanNav Anatomy PNB highlighting performance independently from the participant. The majority opinion (at least 2/3) will be obtained to establish the agreement (e.g., yes/yes/no = yes)
- The answers obtained during the scan session from participants will be compared to expert panel view. Independent comparisons between performance assessment will be made, providing that the expert panel view is the 'ground truth'.
- Data will be evaluated and presented by safety structure on each model and overall (i.e., total for each class of safety critical structure; nerve, artery etc.).
- Being tested
- Ultrasound scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanningDevice
All participants will scan with and without device and trainee on 4 models. The order of the device assistance and models will be randomized between participants, but participant will always have exposure to device first before supervising the trainee.
| Study group | Role | What they receive |
|---|---|---|
| Participant | All 15 participants must be anesthesiologists who are competent to perform UGRA independently. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified and licensed Medical Doctor. Receives: Device: Ultrasound scanning | |
| Trainee | All 15 trainees must be healthcare practitioners who are licensed to perform UGRA. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified health practitioner Receives: Device: Ultrasound scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining the correct ultrasound view
Number of participants obtaining the correct ultrasound view [majority view, at least 8/15 participants in agreement]
Measured: 6 months
Secondary outcomes (4)
Identifying anatomical structures
Number of participants identifying the correct anatomical structures in adult patients up to BMI 35 kg/m2 [majority view, at least 8/15 participants in agreement]
Measured: 6 months
Effect of supervision in anatomical structure identification
Number of participants identifying the correct anatomical structures while being supervised in UGRA scanning [majority view, at least 8/15 participants in agreement]
Measured: 6 months
Measuring operator confidence
Number of participants with improved confidence [majority view, at least 8/15 participants in agreement]
Measured: 6 months
Number of errors in anatomy recognition by participants
Number of errors in anatomy recognition by participants [per class of safety critical structure, for all models]
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start16 May 2021
- Primary completion22 May 2021
- Study completion30 Nov 2021
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntelligentUltrasound Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Woodworth, MD, Principal investigator, Oregon Health and Science UniversityJames Bowness, MD, Principal investigator, University of Oxford & Royal Gwent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918693
- Sponsor's protocol ID
- IU2021_AG_08
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bowness JS, El-Boghdadly K, Woodworth G, Noble JA, Higham H, Burckett-St Laurent D. Exploring the utility of assistive artificial intelligence for ultrasound scanning in regional anesthesia. Reg Anesth Pain Med. 2022 Jun;47(6):375-379. doi: 10.1136/rapm-2021-103368. Epub 2022 Jan 28.
PubMed 35091395
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance and Potential Benefits of an Assistive Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block - US V1.0 for Ultrasound-guided Regional Anesthesia
- ClinicalTrials.gov ID
- NCT04918693
- Acronym / sponsor ID
- IU2021_AG_08
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- IntelligentUltrasound LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 May 2021 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 9 Jun 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-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to provide data on the clinical performance of ScanNav Anatomy PNB for identification of anatomical structures during UGRA scanning, in particular:
- Assess the benefits of the device to intended users when supervising a trainee who is performing UGRA scanning.
- Assess the benefits of the device when intended users perform UGRA scanning.
- Assess risk mitigation by the intended users when performing UGRA scanning.
Detailed description
Background:
The American Society of Regional Anesthesia and Pain Medicine (ASRA) has published evidence-based assessment of ultrasound-guided regional anesthesia (Neal et al., 2010) concluding that ultrasound guidance is superior or equal to other non-ultrasound nerve localization techniques. A subsequent publication from ASRA (Neal et al., 2016), has strengthened their position of ultrasound guidance being superior than other methods, including for the reduction of local anesthetic systemic toxicity. However, ultrasound-guided regional anesthesia (UGRA) is a difficult technique to master. A key activity of UGRA is ultrasound image interpretation (Sites et al., 2009) which ScanNav Anatomy PNB is designed to support.
Methodology:
15 participants (anesthesiologists capable of independently performing UGRA) will be recruited to evaluate the performance and benefit of ScanNav Anatomy PNB device in person, by scanning 2 healthy models (n=1 BMI<30, n=1 BMI>=30 kg/m2).
The device performance and benefits will be ascertained once the scanning session for each block is complete by use of a structured questionnaire.
- Participants will be asked to scan a model with and without the use of ScanNav Anatomy PNB. The order of with/without the device will be randomized between participants.
- Participants will also be asked to supervise a trainee (another healthcare professional qualified to perform the UGRA procedure under supervision) while they are scanning models with and without ScanNav Anatomy PNB aid. The participant will always use the device first before supervising the trainee.
- The above will be performed on 2 models from different BMI categories (n=1 BMI<30, n=1 BMI>=30 kg/m2; total scans n=16).
- The order of models will be randomized between participants.
- All 9 supported regions will be evaluated; each region will be scanned/evaluated at least 3 times.
Data collection
- Participants and trainees will be asked to complete a structured questionnaire to assess the device performance and clinical benefits at the end of scanning for the block.
Data analysis:
- Data will be aggregated and evaluated on safety critical structure type basis.
- Quantitative data obtained from the participants will be presented as frequencies and expressed as percent of total or as mean ± s.d. where appropriate.
The collected data and overall performance and benefits of ScanNav Anatomy PNB will be evaluated and summarized by presence and absence of ScanNav Anatomy PNB assistance, trainee and stratified by low/high BMI model.
Independent expert evaluation
- The scans be recorded during the study sessions. These scans will be post processed to short clips (10 seconds prior to obtaining optimum view) and sent for evaluation to an independent expert panel.
- The expert panel will be asked to evaluate the scans and the ScanNav Anatomy PNB highlighting performance independently from the participant. The majority opinion (at least 2/3) will be obtained to establish the agreement (e.g., yes/yes/no = yes)
- The answers obtained during the scan session from participants will be compared to expert panel view. Independent comparisons between performance assessment will be made, providing that the expert panel view is the 'ground truth'.
- Data will be evaluated and presented by safety structure on each model and overall (i.e., total for each class of safety critical structure; nerve, artery etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant | – | Device: Ultrasound scanningAll 15 participants must be anesthesiologists who are competent to perform UGRA independently. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified and licensed Medical Doctor. |
| Trainee | – | Device: Ultrasound scanningAll 15 trainees must be healthcare practitioners who are licensed to perform UGRA. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified health practitioner |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants All participants must be anesthesiologists who are competent to perform UGRA independently. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified and licensed Medical Doctor. Trainees All trainees must be healthcare practitioners who are licensed to perform UGRA. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified health practitioner. Models 4 models will be selected carefully based on their BMI inclusion criteria.
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 scanningAll participants will scan with and without device and trainee on 4 models. The order of the device assistance and models will be randomized between participants, but participant will always have exposure to device first before supervising the trainee. | Device | Participant, Trainee |
Primary outcome
Obtaining the correct ultrasound view
Time frame: 6 months
Number of participants obtaining the correct ultrasound view [majority view, at least 8/15 participants in agreement]
4 secondary outcomes
Identifying anatomical structures
Time frame: 6 months
Effect of supervision in anatomical structure identification
Time frame: 6 months
Measuring operator confidence
Time frame: 6 months
Number of errors in anatomy recognition by participants
Time frame: 6 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 1 Apr 2022.
- Derived from this study: PubMed 35091395Bowness JS, El-Boghdadly K, Woodworth G, Noble JA, Higham H, Burckett-St Laurent D. Exploring the utility of assistive artificial intelligence for ultrasound scanning in regional anesthesia. Reg Anesth Pain Med. 2022 Jun;47(6):375-379. doi: 10.1136/rapm-2021-103368. Epub 2022 Jan 28.
- 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.
Glenn Woodworth, MD principal investigator
Oregon Health and Science University
James Bowness, MD principal investigator
University of Oxford & Royal Gwent Hospital
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 States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Apr 2022. 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 States. 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?
Obtaining the correct ultrasound view (time frame: 6 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 NCT04918693, 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 1 Apr 2022.