Efficacy of a Novel Medical Device to Aid in Ultrasound-Guided Intravenous Cannulation: Randomized Controlled Non-Clinical Trial

Abstract Background Peripheral intravenous (PIV) cannulation is a crucial and frequently performed medical procedure, but achieving successful venous access can be particularly challenging in patients with difficult venous access (DVA). This challenge often leads to procedural delays and increased patient discomfort, as well as higher risks of complications such as hematomas, phlebitis, and infection. The complexity of ultrasound-guided PIV (USPIV) procedures, particularly for novice practitioners, necessitates technological innovations to improve success rates and reduce cannulation time. Objective This study aimed to evaluate the efficacy of a novel medical device designed to aid in USPIV by stabilising the ultrasound probe and assisting with needle guidance. Specifically, we assessed its impact on reducing cannulation time and improving first-attempt success rates, particularly for novice users. Methods A randomized, controlled trial was conducted using a synthetic phantom model to simulate DVA. Participants were stratified by experience level into novice, experienced, and expert groups. The primary outcome measures were cannulation time and first-attempt success rate. Secondary outcomes included the overall success rate of cannulation and user feedback on the device’s usability. Results The device demonstrated a significant 46% reduction in cannulation time compared to traditional USPIV techniques. Novice users saw improvements in both cannulation speed and first-attempt success rates, which increased by 35%. Overall, the device improved first-attempt success rates by 29% across all participants. User feedback indicated that the device reduced procedural complexity and improved hand-eye coordination, especially for less experienced practitioners. Conclusion The novel stabilising device significantly enhances USPIV performance by reducing cannulation time and increasing first-attempt success rates. Its benefits are particularly notable for novice practitioners, offering the potential to reduce the learning curve associated with USPIV and improve clinical efficiency in high-stress environments such as emergency departments. Further clinical studies in real-world patient settings are warranted to confirm these findings and assess the long-term impact on training and healthcare costs.