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

NCT05388175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-26

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome in Preterm Infants

Interventions

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

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2022-06-05
Completion
2022-06-05

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388175 on ClinicalTrials.gov