A Handheld Robot for Pediatric PIVC: Device Design and Preclinical Trial

摘要

Peripheral Intravenous Catheterization (PIVC) is often required in hospitals to fulfill urgent needs for blood sampling or fluid/medication administration. Although PIVC is often easy and successful in adults, it is a very difficult procedure for young pediatric patients. Multiple attempts of catheter insertion are typically needed before a successful placement, especially for clinical personnel lacking specific expertise on this task. The risks of such multiple attempts can be severe and life-threatening as they can cause serious extravasation injuries. Given the levels of precision and controllability needed for PIVC, robotic systems have large potential to effectively assist the operation and improve its success rate. Therefore, this research aims to provide such robotic assistance by focusing on the most challenging part of the operation: the insertion depth control to precisely access the target vein. A handheld robot for controlling the insertion and detecting venipuncture is introduced and evaluated in this paper. The device is small and lightweight, based on a single linear actuator and a real-time electrical impedance sensing system able to identify contact with blood and precisely stop the needle inside the target vein. It works in collaboration with the user, providing the needed assistance to significantly facilitate and improve PIVC operations. This is assessed through a series of comparative experiments conducted on a realistic PIVC scenario involving a baby arm phantom and naïve subjects. The experimental results proved the new handheld robot significantly improves the success rate of pediatric PIVC, allowing an amazing first-stick success rate of 60% and 100% success within two attempts. In addition, the system was highly rated in terms of usability based on feedback received from post-trial questionnaires. These results support continued investment in the technology to bring it to clinical use as soon as possible.