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
Condition: Ultrasound Imaging of Anatomical Structures
Study type: Observational

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. Assess the benefits of the device to intended users when supervising a trainee who is
           performing UGRA scanning.

        2. Assess the benefits of the device when intended users perform UGRA scanning.

        3. 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.).
    

Intervention name(s): Ultrasound scanning
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
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.