Low Cost Image Guidance for Improved Vessel Cannulation in Pediatric Patients

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Clear Guide Medical, Inc. Summary The use of ultrasound for placement of many IVs in pediatric cases has significantly enhanced the success of Central Vein Catheterizations ("CVCs"), although ultrasound can often be hard for non- specialists to use. Although ultrasound guidance can certainly facilitate vascular access, it takes practice and experience to master the real-time ultrasound, free hand technique. The value of this SBIR project is to use technology to broaden the number of clinicians who can safely and quickly perform these important procedures, thereby also reducing hospital costs by freeing up Interventional Radiology or Anesthesia specialists. This application describes the technological research plan to address key technical product developments to adapt the FDA-cleared SCENERGY to the pediatric market for CVCs and to obtain clinical data to demonstrate that the addition of the needle-guidance technology increases the accuracy and speed of non-specialist in vessel cannulation. Public health implications of this proposal include reducing the number of attempts to cannulate children as well as the speed with which this is accomplished. This reduces the psychological stress of patients and their parents. More importantly, the number of needle insertions is correlated with complications, so a reduction in needle insertions/complications has both commercial and non-commercial importance. Finally, by broadening the number of clinicians able to successfully perform CVCs, this proposal ameliorates health disparities that arise from access to care limitations.