Respiratory Distress Syndrome in Preterm Infants
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERigid catheter
Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration
DEVICESoft catheter
Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration
Sponsors
University Hospital Padova
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician will be blinded of the treatment group
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Level III NICU consultants and residents will be eligible to participate in the study
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total time of device (catheter) positioning | 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
| Measure | Time frame | Description |
|---|---|---|
| Achievement of the correct depth of the catheter in the trachea | 5 minutes | The correct depth of the catheter tip in the trachea will be evaluated by an external observer |
| Success of device positioning at the first attempt | 1 minute | We will evaluate the success of the device (catheter) at the first attempt |
| Participant's opinion regarding the procedure | 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 |
Countries
Italy
Outcome results
None listed