Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).
Full description
The investigators will apply crossover comparison in preterm infants who received a ventilatory support. In patient whose frequency of mandatory support is under 25, the two ventilatory modes (SIMV+PSV and NAVA) are delivered by the same ventilator (Servo-I; Maquet Critical Care AB, Solna, Sweden) and will set to maintain similar blood gas analysis results.
Determination of the type of ventilatory mode used is performed using a cluster randomization. The randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. To rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. Recordings will be obtained over a total 8 hours.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- preterm infants mechanically ventilated
- ventilatory set frequency is under 25
- with informed consent of their parents
Exclusion criteria
- major congenital anomalies
- patients without self respiratory effort
- use of sedative or anesthetic drugs
- grade III or IV intraventricular hemorrhage
- phrenic nerve palsy or insufficiency
Trial design
Primary purpose
Allocation
Interventional model
Masking
26 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal