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

Not Applicable

Completed

Interventions: Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter
Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Level III NICU consultants and residents will be eligible to participate in the study

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter	Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter	Participants will be assigned to perform the procedure with a LISA catheter with a marked tip
Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter	Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter	Participants will be assigned to perform the procedure with a LISA catheter with an unmarked tip

Primary Outcome Measures

Name	Time	Method
Number of participants who will achieve the positioning of the device at the correct depth in the trachea	5 minutes	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).

Secondary Outcome Measures

Name	Time	Method
Participant opinion on using the device	10 minutes	Participant opinion on using the device which will be evaluated using a Likert scale (1 worse outcome to 5 best outcome)
Number of attempts for positioning the device in the trachea	5 minutes	The total number of attempts for positioning the device in the trachea
Time for positioning the device in the trachea	5 minutes	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