LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS

LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS: a Crossover Randomized Controlled Manikin Trial

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure). The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction. This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Participants in AB arm will be assigned to perform the procedure with LISA catheter with marked tip, followed by the procedure with LISA catheter with unmarked tip. Participants in BA arm will be assigned to the reverse sequence. A washout period of 6 hours (one procedure in the morning and one in the afternoon) will be included to reduce any carryover effect

Due to the characteristics of the intervention, both participants and outcome assessors cannot be masked. The statistician will be blind to the intervention arms.

Number of participants who will achieve the positioning of the device at the correct depth in the trachea

Number of participants who will achieve the positioning of the device at the correct depth in the trachea (as assessed by the external observer using a laryngoscope).

The time of device positioning will be defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe to the catheter

Participant opinion on using the device which will be evaluated using a Likert scale (1 worse outcome to 5 best outcome)

Inclusion Criteria: Level III NICU consultants and residents will be eligible to participate in the study Exclusion Criteria: Refusal to participate in the study.

Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.