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

University Hospital Padova

Status: Completed

Conditions: Respiratory Distress Syndrome in Preterm Infants

Treatments: Device: Rigid catheter; Device: Soft catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05388175

NEOUNIPD1(2022)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Less invasive surfactant administration (LISA) with a rigid catheter

Experimental group

Description:

Participants will simulate the procedure of surfactant administration by using a rigid catheter

Treatment:

Device: Rigid catheter

Less invasive surfactant administration (LISA) with a soft catheter

Active Comparator group

Description:

Participants will simulate the procedure of surfactant administration by using a soft catheter

Treatment:

Device: Soft catheter