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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome in Preterm Infants
• Interventions: Device: Rigid catheter; Device: Soft catheter

• Registration Number: NCT05388175
• Lead Sponsor: University Hospital Padova

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.

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-24
• Study Start: 2022-05-25
• Primary Completion: 2022-06-05
• Study Completion: 2022-06-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• There are no exclusion criteria for this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Less invasive surfactant administration (LISA) with a rigid catheter	Rigid catheter	Participants will simulate the procedure of surfactant administration by using a rigid catheter
Less invasive surfactant administration (LISA) with a soft catheter	Soft catheter	Participants will simulate the procedure of surfactant administration by using a soft catheter

Primary Outcome Measures

Name	Time	Method
Total time of device (catheter) positioning	5 minutes	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

Secondary Outcome Measures

Name	Time	Method
Achievement of the correct depth of the catheter in the trachea	5 minutes	The correct depth of the catheter tip in the trachea will be evaluated by an external observer
Participant's opinion regarding the procedure	5 minutes	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
Success of device positioning at the first attempt	1 minute	We will evaluate the success of the device (catheter) at the first attempt

Trial Locations

Locations (2)

Poliambulanza Breacia; 🇮🇹 Brescia, Italy

Azienda Ospedaliera di Padova, University of Padova; 🇮🇹 Padova, Italy