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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome in Preterm Infants
• Intervention / Treatment: Device: Rigid catheter; Device: Soft catheter

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy
    • Poliambulanza Breacia
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova, University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Less invasive surfactant administration (LISA) with a rigid catheter; Participants will simulate the procedure of surfactant administration by using a rigid catheter	Device: Rigid catheter; Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration; Other Names: Less invasive surfactant administration (LISA) with a rigid catheter
ACTIVE_COMPARATOR: Less invasive surfactant administration (LISA) with a soft catheter; Participants will simulate the procedure of surfactant administration by using a soft catheter	Device: Soft catheter; Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration; Other Names: Less invasive surfactant administration (LISA) with a soft catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time of device (catheter) positioning	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	5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Padova

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2022
• Primary Completion (ACTUAL): June 5, 2022
• Study Completion (ACTUAL): June 5, 2022

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (ACTUAL): May 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: NEOUNIPD1(2022)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be shared upon motivated request to the PI
• IPD Sharing Access Criteria: Upon motivated request to the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No