Development of a Novel Ultrasound-Guided Needle Cricothyroidotomy Device

<b>Background:</b> Ultrasound-guided identification of the cricothyroid membrane is more accurate than traditional palpation techniques. Additionally, real-time ultrasound-guided puncture is more precise than ultrasound alone. However, no dedicated device currently exists for ultrasound-guided needle cricothyroidotomy. In this study, we aimed to develop and evaluate a novel ultrasound-guided cricothyroidotomy device. <b>Methods:</b> A randomized, prospective, crossover simulation study was conducted using a porcine larynx model. Sixteen anesthesiologists and six anesthesia residents participated after receiving video-based and hands-on training. Each participant performed cricothyroidotomy using three methods: ultrasound-guided needle cricothyroidotomy using the novel device (US-G), needle cricothyroidotomy using a commercial cricothyroidotomy kit (QuickTrach^®), and scalpel incisional cricothyroidotomy after conventional palpation identifying the cricothyroid membrane (Pal-SI). The primary outcome was the puncture success rate. Secondary outcomes included procedure time and tracheal wall injury rates. <b>Results:</b> Cricothyroidotomy of the porcine larynx had a success rate of 100% for US-G and Pal-C and 95% for Pal-SI. The US-G procedure time was significantly longer (median: 80 s) than for Pal-C (22 s) or Pal-SI (51 s). No significant differences in the tracheal wall injury rates were noted across methods, and no severe injuries were reported in the US-G group. <b>Conclusions:</b> US-G demonstrated a high success rate and good safety profile. Although the procedure time was longer than other methods, its precision may still be beneficial in cases involving anticipated difficult airways. Further clinical validation is warranted.