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:
Condition or disease | Intervention/treatment |
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Ultrasound Imaging of Anatomical Structures | Device: Ultrasound scanning |
Study Type : | Observational |
Estimated Enrollment : | 34 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | May 16, 2021 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | November 2021 |
Group/Cohort | Intervention/treatment |
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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.
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Device: Ultrasound scanning
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.
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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
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Device: Ultrasound scanning
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.
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
Participant exclusion criteria
Trainee Inclusion criteria
Trainee exclusion criteria
Models Inclusion Criteria
Model Exclusion Criteria
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Glenn Woodworth, MD | Oregon Health and Science University | |
Principal Investigator: | James Bowness, MD | University of Oxford & Royal Gwent Hospital |
Tracking Information | |||||||
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First Submitted Date | May 25, 2021 | ||||||
First Posted Date | June 9, 2021 | ||||||
Last Update Posted Date | June 9, 2021 | ||||||
Actual Study Start Date | May 16, 2021 | ||||||
Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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]
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief 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 | ||||||
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 | ||||||
Brief 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:
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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.
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:
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
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
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. |
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Condition | Ultrasound Imaging of Anatomical Structures | ||||||
Intervention | Device: Ultrasound scanning
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.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Enrolling by invitation | ||||||
Estimated Enrollment |
34 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | November 2021 | ||||||
Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Participant Inclusion criteria
Participant exclusion criteria
Trainee Inclusion criteria
Trainee exclusion criteria
Models Inclusion Criteria
Model Exclusion Criteria
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT04918693 | ||||||
Other Study ID Numbers | IU2021_AG_08 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | IntelligentUltrasound Limited | ||||||
Study Sponsor | IntelligentUltrasound Limited | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | IntelligentUltrasound Limited | ||||||
Verification Date | June 2021 |