An interventional study of Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter and Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter in Respiratory Distress Syndrome, Newborn, sponsored by University Hospital Padova. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by University Hospital Padova · Not applicable, Interventional, and Treatment
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.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University Hospital Padova is the lead sponsor of 41 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participants will be assigned to perform the procedure with a LISA catheter with a marked tip
Device: Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter
Participants will be assigned to perform the procedure with a LISA catheter with an unmarked tip
Device: Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
Participants will be assigned to perform the procedure with LISA catheter with a marked tip
Participants will be assigned to perform the procedure with LISA catheter with an unmarked tip
Number of participants who will achieve the positioning of the device at the correct depth in the trachea
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).
Time frame: 5 minutes
Time for positioning the device in the trachea
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
Time frame: 5 minutes
Number of attempts for positioning the device in the trachea
The total number of attempts for positioning the device in the trachea
Time frame: 5 minutes
Participant opinion on using the device
Participant opinion on using the device which will be evaluated using a Likert scale (1 worse outcome to 5 best outcome)
Time frame: 10 minutes
Plan to share: Yes — The data will be available upon motivated request to the corresponding author
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
University Hospital Padova