Evaluation of a Semi-Automated Ultrasound Guidance System for Central Vascular Access.

Abstract

Hemorrhage remains a leading cause of death in both military and civilian trauma settings. Oftentimes, the control and treatment of hemorrhage requires central vascular access and well-trained medical personnel. Automated technology is being developed that can lower the skill threshold for life-saving interventions. Here, we conduct independent evaluation testing of one such device, the Vu-Path™ Ultrasound Guidance system, or Vu-Path™. The device was designed to simplify needle insertion using a needle holder that ensures the needle is within the ultrasound field of view during its insertion into tissue, along with guidance lines shown on the user interface. We evaluated the performance of this device in a range of laboratory, animal, and human testing platforms. Overall, the device had a high success rate, achieving an 83% insertion accuracy in live animal testing across both normal and hypotensive blood pressures. Vu-Path™ was faster than manual, ultrasound-guided needle insertion and was nearly 1.5 times quicker for arterial and 2.3 times quicker for venous access. Human usability feedback highlighted that 80% of the participants would use this device for central line placement. Study users noted that the guidance lines and small form factor were useful design features. However, issues were raised regarding the needle insertion angle being too steep, with potential positioning challenges as the needle remains fixed to the ultrasound probe. Regardless, 75% of the participants believed that personnel with any level of clinical background could use the device for central vascular access. Overall, Vu-Path™ performed well across a range of testing situations, and potential design improvements were noted. With adjustments to the device, central vascular access can be made more accessible on battlefields in the future.