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OpenTrials
Completed

NCT Number: NCT05399628

LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip 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 positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

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Key information

About this study

Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure).

The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction.

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip 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 positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Who can participate

Healthy volunteers accepted: Yes

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

  • Refusal to participate in the study.

Treatment and study plan

Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter

Device

Participants will be assigned to perform the procedure with LISA catheter with a marked tip

Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter

Device

Participants will be assigned to perform the procedure with LISA catheter with an unmarked tip

Primary outcomes

  1. Number of participants who will achieve the positioning of the device at the correct depth in the trachea

    Time frame: 5 minutes

    Number of participants who will achieve the positioning of the device at the correct depth in the trachea (as assessed by the external observer using a laryngoscope).

Secondary outcomes

  1. Time for positioning the device in the trachea

    Time frame: 5 minutes

    The time of device positioning will be defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe to the catheter

  2. Number of attempts for positioning the device in the trachea

    Time frame: 5 minutes

    The total number of attempts for positioning the device in the trachea

  3. Participant opinion on using the device

    Time frame: 10 minutes

    Participant opinion on using the device which will be evaluated using a Likert scale (1 worse outcome to 5 best outcome)

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS: a Crossover Randomized Controlled Manikin Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 1, 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.

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