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.
Keywords: Less invasive surfactant administration; manikin; preterm infant; surfactant.