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OpenTrials
Completed

NCT Number: NCT05388175

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

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.

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Key information

Conditions

Respiratory Distress Syndrome in Preterm Infants

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poliambulanza Breacia, Brescia, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rigid catheter

Device

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

Soft catheter

Device

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

Primary outcomes

  1. Total time of device (catheter) positioning

    Time frame: 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 outcomes

  1. Success of device positioning at the first attempt

    Time frame: 1 minute

    We will evaluate the success of the device (catheter) at the first attempt

  2. Achievement of the correct depth of the catheter in the trachea

    Time frame: 5 minutes

    The correct depth of the catheter tip in the trachea will be evaluated by an external observer

  3. Participant's opinion regarding the procedure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

Time of Device Positioning of LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin: A Crossover Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 24, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.