A Novel Prototype Neonatal Resuscitator That Controls Tidal Volume and Ventilation Rate: A Comparative Study of Mask...

The objective of this randomized controlled manikin trial was to examine tidal volume (V_T) delivery and ventilation rate during mask positive pressure ventilation (PPV) with five different devices, including a volume-controlled prototype Next Step™ device for neonatal resuscitation. We hypothesized that V_T and rate would be closest to target with the Next Step™. Twenty-five Neonatal Resuscitation Program providers provided mask PPV to a newborn manikin (simulated weight 1 kg) in a randomized order with a self-inflating bag (SIB), a disposable T-piece, a non-disposable T-piece, a stand-alone resuscitation system T-piece, and the Next Step™. All T-pieces used a peak inflation pressure of 20 cmH₂O and a positive end-expiratory pressure of 5 cmH₂O. The participants were instructed to deliver a 5 mL/kg V_T (rate 40-60/min) for 1 min with each device and each of three test lungs with increasing compliance of 0.5, 1.0, and 2.0 mL/cmH₂O. V_T and ventilation rate were compared between devices and compliance levels (linear mixed model). All devices, except the Next Step™ delivered a too high V_T, up to sixfold the target at the 2.0-mL/cmH₂O compliance. The Next Step™ V_T was 26% lower than the target in the low compliance. The ventilation rate was within target with the Next Step™ and SIB, and slightly lower with the T-pieces. In conclusion, routinely used newborn resuscitators over delivered V_T, whereas the Next Step™ under delivered in the low compliant test lung. The SIB had higher V_T and rate than the T-pieces. More research is needed on volume-controlled delivery room ventilation.