Novel Assistive Devices for Umbilical Artery Catheterisation

Abstract

Background: 300+ neonates/year in a New Zealand neonatal intensive care unit (NICU) need umbilical arterial catheterisation (UAC), of whom 7.5% die or have permanent impairment because an umbilical arterial catheter could not be inserted. Complexities associated with the procedure can lead to lengthy procedure times and increased risk of catheterisation failure, increasing the risk of poor outcomes. While several manual techniques are used, very few use assistive devices. Objective: Design and test assistive devices to significantly simplify UAC. Methods: Main requirements include: 1) insertion time <15 minutes; 2) only one practitioner required. The procedure requires two primary tasks: 1) traction (tensioning) of the umbilical cord; 2) dilation of the umbilical artery to admit the (wider, 5F) catheter. A full design analysis addresses these tasks and requirements. Prototypes are evaluated by a NICU clinician using a silicone phantom umbilical cord. Results: A two-device solution was developed, comprising a hands-free traction device and a dilation device. The traction device utilises a small hair-cliplike device with torsional spring and stabilising skirt. The dilator comprises an insertor and a sheath. The insertor tip diameter of 0.1 mm allows easy insertion, while the following sheath dilates the artery to allow catheter insertion. All devices are removed after insertion. UAC time decreased an average of 51.8% over 6 tests versus without assistive devices, and only one practitioner was required. Conclusions: The coordination, complexity, and time for UAC were significantly reduced, using simple, novel assistive devices, which could improve outcomes for infants suffering negative outcomes due to UAC insertion failure.