Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Seoul National University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants

Treatments: Device: noninvasive respiratory support with NAVA mode and PSV

Study type: Interventional

Funder types: Other

Identifiers

NCT01877720

NIV-NAVA Physiologic Study

Details and patient eligibility

About

Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).

Enrollment: 16 patients

Sex: All

Ages: 3 days to 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preterm infants less than 32 weeks of gestational age
• intubated more than 48 hours after birth
• subjected to extubation with minimal ventilator setting (mean airway pressure < 7cmH2O + peak inspiratory pressure < 13 cmH2O + FiO2 < 0.4 + respiratory rate < 35/min)
• with informed consent from parents

Exclusion criteria

• with major congenital anomalies
• use of sedative or anesthetic drugs
• hemodynamic instability
• grade 3 or higher intraventricular hemorrhage
• phrenic nerve palsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

NAVA-PS

Experimental group

Description:

noninvasive NAVA first for 15 minutes and then PSV for 15 minutes

Treatment:

Device: noninvasive respiratory support with NAVA mode and PSV

PS-NAVA

Experimental group

Description:

noninvasive PSV first for 15 minutes and then NAVA for 15 minutes

Treatment:

Device: noninvasive respiratory support with NAVA mode and PSV