Respiratory Distress Syndrome, Newborn
Conditions
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.
Interventions
DEVICESurfactant administration with less invasive surfactant administration (LISA) marked tip catheter
Participants will be assigned to perform the procedure with LISA catheter with a marked tip
DEVICESurfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
Participants will be assigned to perform the procedure with LISA catheter with an unmarked tip
Sponsors
University Hospital Padova
Study design
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.
Intervention model description
Participants in AB arm will be assigned to perform the procedure with LISA catheter with marked tip, followed by the procedure with LISA catheter with unmarked tip. Participants in BA arm will be assigned to the reverse sequence. A washout period of 6 hours (one procedure in the morning and one in the afternoon) will be included to reduce any carryover effect
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who will achieve the positioning of the device at the correct depth in the trachea | 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
| Measure | Time frame | Description |
|---|---|---|
| Time for positioning the device in the trachea | 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 |
| Number of attempts for positioning the device in the trachea | 5 minutes | The total number of attempts for positioning the device in the trachea |
| Participant opinion on using the device | 10 minutes | Participant opinion on using the device which will be evaluated using a Likert scale (1 worse outcome to 5 best outcome) |
Countries
Italy
Outcome results
None listed