Background: Real-time ultrasound (US) guidance facilitates central venous catheterization in intensive care unit (ICU). New magnetic needle-pilot devices could improve efficiency and safety of central venous catheterization. This simulation trial was aimed at comparing venipuncture with a new needle-pilot device to conventional US technique. Methods: In a prospective, randomized, simulation trial, 51 ICU physicians and residents cannulated the right axillary vein of a human torso mannequin with standard US guidance and with a needle-pilot system, in a randomized order. The primary outcome was the time from skin puncture to successful venous cannulation. The secondary outcomes were the number of skin punctures, the number of posterior wall puncture of the axillary vein, the number of arterial punctures, the number of needle redirections, the failure rate, and the operator comfort. Results: Time to successful cannulation was shorter with needle-pilot US-guided technique (22 s (interquartile range (IQR) = 16–42) vs 25 s (IQR = 19–128); median of difference (MOD) = −9 s (95%-confidence interval (CI) −5, −22), p < 0.001). The rates of skin punctures, posterior wall puncture of axillary vein, and needle redirections were also lower ( p < 0.01). Comfort was higher in needle-pilot US-guided group on a 11-points numeric scale (8 (IQR = 8–9) vs 6 (IQR = 6–8), p < 0.001). Conclusions: In a simulation model, US-guided axillary vein catheterization with a needle-pilot device was associated with a shorter time of successful cannulation and a decrease in numbers of skin punctures and complications. The results plea for investigating clinical performance of this new device.
Objective Assessment Metrics for Central Line Simulators: An Exploration of Causal Factors
