Patients in the trial were randomly assigned to either the manual palpation control or Accuro US group. The Accuro patient group was scanned prior to needle insertion with the handheld, battery operated device to visualize spine bony landmarks and identify the appropriate interlaminar space at the desired intervertebral level. The Accuro system itself combines precise, automated 3D image guidance with sophisticated BoneEnhance® image reconstruction technology optimized for high bony anatomy contrast. A flexible, handheld form factor enables real-time operation by the anesthesia provider.
Results were statistically adjusted for variables such as age, gender and BMI within each group. The number of failed blocks in the control group was two but improved in the Accuro group where no failures were observed. Procedures performed with Accuro took slightly longer to perform. Authors suggest that this may be due to the time involved placing a sterile cover over the device because needle placement time was not tracked separately from the procedure overall. While authors acknowledge some limitations to the study, they stress that corrective actions were taken to compensate for these.
“This study is the latest in a growing body of clinical evidence collected from around the world and enlisting more than 600 subjects, all pointing to the same conclusion that an Accuro-guided technique is superior to a ‘blind’ palpation-based approach. This has now been demonstrated irrespective of provider experience level, type of neuraxial anesthesia performed and amount of prior training with the instrument,” comments Will Mauldin. “With this study and Accuro’s trailblazing technology, we anticipate the field will migrate to an image-guided standard of care in neuraxial anesthesia for the benefit of all patients and providers.”
The trial is registered at ClinicalTrials.gov registry (NCT03075488).
About RIVANNA and Accuro
Accuro® by RIVANNA® is the world’s first spinal navigation device designed to improve the safety, speed, and efficiency of epidural and spinal anesthesia. The revolutionary platform features BoneEnhance®, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™, which automates measurements of the spinal midline, epidural depth and trajectory. Accuro was engineered and commercialized by RIVANNA, an innovative medical device company headquartered in Charlottesville, VA. For anesthesia providers, certainty can be effortless with Accuro. For more information, visit rivannamedical.com.
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