Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial

Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.

Abstract

Objective: To compare non-invasive ventilation neurally adjusted ventilatory assist (NIV-NAVA) and non-invasive pressure support (NIV-PS) in preterm infants on patient-ventilator synchrony.

Design: A randomised phase II crossover trial.

Setting: Neonatal intensive care units of two tertiary university hospitals in Korea.

Patients: Preterm infants born <32 weeks.

Intervention: NIV-NAVA and NIV-PS were applied in random order after ventilator weaning. Data were recorded for sequential 5 min periods after 10 min applications of each mode.

Main outcome measures: The electrical activity of the diaphragm (Edi), ventilator flow and pressure curves were compared to examine the trigger delay (primary outcome) and other parameters of patient-ventilator interaction (secondary outcomes) for each period.

Results: Fifteen infants completed the protocol. Trigger delay (35.2±8.3 vs 294.6±101.9 ms, p<0.001), ventilator inspiratory time (423.3±87.1 vs 534.0±165.5 ms, p=0.009) and inspiratory time in excess (32.3±8.3% vs 294.6±101.9%, p=0.001) were lower during NIV-NAVA compared with NIV-PS. Maximum Edi (12.6±6.3 vs 16.6±8.7 μV, p=0.003), swing Edi (8.8±4.8 vs 12.2±8.7 μV, p=0.012) and peak inspiratory pressure (12.3±1.5 vs 14.7±2.7 cm H2O, p=0.003) were also lower during NIV-NAVA. The main asynchrony events during NIV-PS were ineffective efforts and autotriggering. All types of asynchronies except double triggering were reduced with NIV-NAVA. Asynchrony index was significantly lower during NIV-NAVA compared with NIV-PS (p<0.001). No significant differences in leakage, expiratory tidal volume or minute ventilation were observed, but the respiratory rate was lower during NIV-PS than during NIV-NAVA.

Conclusions: NAVA improved patient-ventilator synchrony and diaphragmatic unloading in preterm infants during non-invasive nasal ventilation even in the presence of large air leaks.

Trial registration number: Registered with http://www.clinicaltrials.gov (NCT01877720).

Keywords: Intensive Care; Neonatology; Respiratory.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Cross-Over Studies
  • Diaphragm / physiology
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature
  • Intensive Care Units, Neonatal
  • Interactive Ventilatory Support / methods*
  • Male
  • Noninvasive Ventilation / methods*
  • Republic of Korea
  • Ventilator Weaning

Associated data

  • ClinicalTrials.gov/NCT01877720