Rigid vs. Soft catheter for less invasive surfactant administration (LISA): a crossover randomized controlled manikin trial

Background LISA can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. A difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result in stressful consequences such as bradycardia, hypoxia and hemodynamic changes. Objectives The objectives of the study were to compare two different kinds of LISA catheters, specifically comparing: i) time of device positioning in a manikin simulating an extremely low birth weight infant, ii) success of the procedure of positioning the device, iii) participants’ opinion. Methods This was an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with rigid catheter vs. LISA with soft catheter in a manikin simulating an extremely low birth weight infant. Participants were Neonatal Intensive Care Unite consultants and pediatric residents. Randomization was performed using a computer-generated random assignment list. The primary outcome measure was the total time of device positioning. The secondary outcomes were the success at the first attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant’s opinion on using the device. Results Median time of device positioning was shorter with rigid catheter vs. soft catheter (median difference –17 seconds, 95% confidence interval –26 to -12; p<0.0001). Success at first attempt was 46/50 with the rigid catheter (92%) and 37/50 with soft catheter (74%) (p=0.01). Median number of attempts was 1 (IQR 1-1) with rigid catheter and 1 (IQR 1-2) with soft catheter (p=0.01). Participants found performing LISA with rigid catheter overall difficulty lower (p<0.0001), and they found easier to insert the rigid catheter in the trachea (p<0.0001). Participants also found easier handling the rigid catheter (p<0.0001) and to visualize the glottis (p=0.01). Conclusions Using a rigid versus a soft catheter to perform the LISA procedure on an extremely preterm manikin is faster, more adequate in terms of catheter insertion depth and is more appreciated by operators. Further studies are needed to confirm our findings in clinical practice. Trial Registration The study has been registered in ClinicalTrials.gov NCT05388175.