Device positioning with LISA vs. INSURE: a crossover randomized controlled manikin trial

Objective We aimed to compare time of device positioning, success of procedure and operator's opinion with LISA vs. INSURE in a manikin simulating an extremely low birthweight infant. Methods A randomized controlled crossover (AB/BA) trial of surfactant administration with LISA vs. INSURE in a preterm manikin. Forty-two tertiary hospital consultants and pediatric residents with previous experience with LISA and INSURE participated. The primary outcome measure was the time of device positioning. The secondary outcome measures were: success of the first attempt, number of attempts, correct depth, and participant's opinion on difficulty in using the device. Results Median time of device positioning was shorter with LISA vs. INSURE (median difference -8 s, 95% confidence interval -16 to -1 s; p = .04). Success at first attempt was 35/40 with LISA (83%) and 31/40 with INSURE (74%) (p = .42). Median number of attempts was 1 (IQR 1-1) with LISA and 1 (IQR 1-2) with INSURE (p = .08). Correct depth was achieved in 30/40 with LISA (71%) and 37/40 with INSURE (88%) (p = .12). Participants found LISA easier to insert in the trachea (p = .002) but INSURE easier to place at the correct depth (p = .008). Handling the device (p = .43), visualizing the glottis (p = .17) and overall difficulty in using the device (p = .13) were not statistically different. Conclusions In a preterm manikin model, positioning a thin catheter (LISA) was quicker and easier than a tracheal tube (INSURE), but the magnitude of the difference was unlikely to be clinically relevant and the tracheal tube was easier to place at the correct depth. Registration clinicaltrial.gov NCT04944108.