Clinical trial NCT01389882: Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
Official title: Application of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants and Assessment of Its Benefits Compared to Synchronized Intermittent Mandatory Ventilation (SIMV) With Pressure Support (PS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infant, Preterm
Keywords: mechanical ventilation
diaphragm electrical activity
pressure support
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 26
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Inspiratory Pressure
timeFrame: four hours
Secondary outcomes:
measure: Mean Airway Pressure
timeFrame: four hours
measure: Minute Ventilation
timeFrame: four hours
measure: Expiratory Tidal Volume
timeFrame: four hours
measure: Dynamic Compliance
timeFrame: four hours
measure: Work of Breathing
timeFrame: four hours
measure: Peak EAdi
timeFrame: four hours
measure: Fraction of Oxygen
timeFrame: four hours
measure: Capillary Blood pH
timeFrame: four hours
measure: Capillary Blood pCO2
timeFrame: four hours
measure: Capillary Blood pO2
timeFrame: four hours
measure: Capillary Blood HCO3
timeFrame: four hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han Suk Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: