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

NCT ID: NCT05388175

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2022-06-05

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.

Conditions

Respiratory Distress Syndrome in Preterm Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Less invasive surfactant administration (LISA) with a rigid catheter

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

Group Type: EXPERIMENTAL

Rigid catheter

Intervention Type: DEVICE

Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration

Less invasive surfactant administration (LISA) with a soft catheter

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

Group Type: ACTIVE_COMPARATOR

Soft catheter

Intervention Type: DEVICE

Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration

Interventions

Rigid catheter

Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration

Intervention Type: DEVICE

Soft catheter

Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration

Intervention Type: DEVICE

Other Intervention Names

Less invasive surfactant administration (LISA) with a rigid catheter; Less invasive surfactant administration (LISA) with a soft catheter

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Padova

OTHER

Sponsor Role: lead

Responsible Party

Daniele Trevisanuto

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Poliambulanza Breacia

Brescia, , Italy

Azienda Ospedaliera di Padova, University of Padova

Padua, , Italy

Countries

Italy

Other Identifiers

NEOUNIPD1(2022)

Identifier Type: -

Identifier Source: org_study_id