LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS: a Crossover Randomized Controlled Manikin Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital Padova
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of participants who will achieve the positioning of the device at the correct depth in the trachea
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Due to the characteristics of the intervention, both participants and outcome assessors cannot be masked. The statistician will be blind to the intervention arms.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Level III NICU consultants and residents will be eligible to participate in the study
Exclusion Criteria
- •Refusal to participate in the study.
Arms & Interventions
Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter
Participants will be assigned to perform the procedure with a LISA catheter with a marked tip
Intervention: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter (Device)
Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
Participants will be assigned to perform the procedure with a LISA catheter with an unmarked tip
Intervention: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter (Device)
Outcomes
Primary Outcomes
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
- Number of attempts for positioning the device in the trachea(5 minutes)
- Participant opinion on using the device(10 minutes)
- Time for positioning the device in the trachea(5 minutes)
Investigators
Daniele Trevisanuto
Associate Professor
University Hospital Padova