NCT05388175

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome in Preterm Infants

Interventions

Type	Name	Description
DEVICE	Rigid catheter	Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration
DEVICE	Soft catheter	Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration

Timeline

• Start date: 2022-05-25
• Primary completion: 2022-06-05
• Completion: 2022-06-05
• First posted: 2022-05-24
• Last updated: 2022-07-26

Locations

2 sites across 1 country: Italy