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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Distress Syndrome, Newborn

Intervention / Treatment
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* Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter
* Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Level III NICU consultants and residents will be eligible to participate in the study Exclusion Criteria: Refusal to participate in the study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter<br>Participants will be assigned to perform the procedure with a LISA catheter with a marked tip | Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter<br>* Participants will be assigned to perform the procedure with LISA catheter with a marked tip<br>|
| Active Comparator: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter<br>Participants will be assigned to perform the procedure with a LISA catheter with an unmarked tip | Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter<br>* Participants will be assigned to perform the procedure with LISA catheter with an unmarked tip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 5 minutes | 

Secondary Outcome Measures

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