Background Volume-targeted ventilation is used widely but different modes have not been compared using clinically relevant outcomes.
Aims To compare volume-controlled ventilation (VCV) with volume guarantee (VG) using short-term clinical outcomes in preterm infants with respiratory distress syndrome (RDS).
Methods This RCT recruited in a tertiary UK neonatal unit (ISRCTN no. 04448562). Infants born at <34 weeks’ gestation (w) requiring intubation and ventilation within 24 hours (hrs) of birth were randomised to either VCV or VG delivered using Avea ventilators. Randomisation was stratified by gestational age. Deferred parental consent was sought. The primary outcome was the duration of time from starting the allocated mode until reaching pre-defined ‘success’ criteria (maintaining a mean airway pressure <8cmH2O and FiO2 £0.35 for six consecutive hours followed by a successful spontaneous breathing test). This objective outcome represented readiness for extubation. An initial sample size of 112 infants was calculated to show a 33% reduction in time to ‘success’ criteria using VG (80% power). Data were analysed by intention-to-treat using Kaplan-Meier ‘survival’ probabilities and hazard ratios (HR).
Results 113 infants were enrolled. One ineligible infant was withdrawn. Mean GA and median birth weight in the VCV and VG groups were 27w and 1080g, and 27w and 1020g respectively. Respiratory status at trial entry was comparable between groups. Overall, and within the first 48 hours, there were no significant differences between groups in the primary outcome or in duration of ventilation. There were no differences between groups in important secondary outcome measures.
CI, confidence interval
Conclusion In preterm infants with RDS there was no difference between VCV and VG in time to ‘success’ criteria or in duration of ventilation. Secondary outcome measures were similar irrespective of trial mode.
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