Handheld 3D Lumbar Spine Navigation: A Clinical Validation Study RM002
Condition: Pregnancy
Study type: Observational

Summary: 
      Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are
      only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This
      device uses sound waves to create pictures of the spine in three dimensions. This may allow
      the physician to view the spine in more detail for procedures such as spinal anesthesia and
      other diagnostic procedures. Epidural analgesia is the mainstay procedure for the management
      of labor pain. The precise placement of a needle or catheter in proximity to landmarks of the
      spinal bone anatomy is required for the procedure to succeed. The current standard of care is
      called the 'blind approach' (i.e. without medical imaging) and involves a physician manually
      palpating a patient's back to locate spinal bone landmarks. The needle is then inserted with
      respect to the location of the landmarks and inserted until a loss-of-resistance is manually
      detected. This approach, while most common, has been associated with success rates as low as
      68% in obese patients (2).

      Alternative methods have been investigated for this problem, including ultrasound (US)
      guidance, which offers real-time imaging. Several studies have demonstrated ultrasound's
      efficacy for spinal anesthesia (1-6). However, standard US systems are engineered to image
      soft tissue rather than bone structures, with the consequence that bone is imaged poorly. US
      images are often degraded by a number of noise sources including speckle noise,
      reverberations and off-axis scattering, particularly when bone is present, making
      visualization of bone anatomy features difficult. Moreover, arranging access to ultrasound
      for the purpose of spinal anesthesia alone is cumbersome. Thus, the efficacy of guided spinal
      anesthesia and diagnostic procedures using standard ultrasound systems is limited and the
      benefits that it offers are heavily dependent on the user's familiarity and skill with
      ultrasonography (4).

      Recently, new medical imaging technologies have been developed at Rivanna Medical, LLC to
      address the significant clinical need for technological advances that improve the placement
      of spinal anesthesia, epidural analgesia and other diagnostic procedures. The Accuro is a
      pocket-sized and battery operated ultrasound instrument that incorporates new signal
      processing-based technologies for enhanced bone imaging including 3D navigation of the lumbar
      spine. The device is a single self-contained unit consisting of an ultrasound system,
      ultrasound probe, and rotatable touchscreen display. The instrument enables a SpineView3D™
      technology to facilitate spinal anesthesia guidance with real-time 3D navigation of the
      lumbar spine anatomy.

      SpineView3D™ technology facilitates image interpretation of individual 2D lumbar spine scans
      by automating spinal bone landmark detection and depth measurements and providing a real-time
      assessment of scan plane orientation in 3D. SpineView3D™ makes image interpretation and
      measurements of the lumbar spine anatomy simple, quick, and easy. Real-time 2D scans from
      either SpineView3D™ or general-purpose bone presets are formed using patent-pending
      BoneEnhance+™ technology. The BoneEnhance+™ technology provides images of bone anatomy at
      greater bone-to-tissue contrast compared with conventional ultrasound image reconstructions.
    


Intervention name(s): Control group (CG): standard practice; Ultrasound group (UG):; Accuro SpineView3D™
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Standard practice group; SpineView3D™ anatomical "scouting" approach; subject will be scanned with 'Accuro SpineView3D
Other intervention name(s): CG; UG; scan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the ages of 18 and 40 presenting for delivery and planning epidural
        anesthesia.