LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin

Study Overview
=================
Brief Summary
-----------------
Less invasive surfactant administration (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: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.

Detailed Description
-----------------
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with a rigid catheter vs. LISA with a soft catheter 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 total time of device positioning. The secondary outcomes will be the success of 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.

Official Title
-----------------
Time of Device Positioning of LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin: A Crossover Randomized Controlled Trial

Conditions
-----------------
Respiratory Distress Syndrome in Preterm Infants

Intervention / Treatment
-----------------
* Device: Rigid catheter
* Device: Soft catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Level III NICU consultants and residents will be eligible to participate in the study Exclusion Criteria: There are no exclusion criteria for this study
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Less invasive surfactant administration (LISA) with a rigid catheter<br>Participants will simulate the procedure of surfactant administration by using a rigid catheter | Device: Rigid catheter<br>* Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration<br>* Other names: Less invasive surfactant administration (LISA) with a rigid catheter;|
| Active Comparator: Less invasive surfactant administration (LISA) with a soft catheter<br>Participants will simulate the procedure of surfactant administration by using a soft catheter | Device: Soft catheter<br>* Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration<br>* Other names: Less invasive surfactant administration (LISA) with a soft catheter;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time of device (catheter) positioning | The time of device positioning defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe for surfactant administration to the catheter | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of device positioning at the first attempt | We will evaluate the success of the device (catheter) at the first attempt | 1 minute | 
| Achievement of the correct depth of the catheter in the trachea | The correct depth of the catheter tip in the trachea will be evaluated by an external observer | 5 minutes | 
| Participant's opinion regarding the procedure | Participant's opinion regarding the feasibility or difficulty of the procedure will be evaluated by using a questionnaire with items (1 worse to 5 best outcome) to be evaluated by a Likert scale | 5 minutes |