Performance and safety of volume guarantee ventilation in neonates using the fabian ventilator, a multicenter study

Objective: To evaluate the performance (i.e., agreement between set and measured parameters) and safety (adverse events, device malfunctions, and ventilator alarms) of the fabian HFOi neonatal ventilator in volume guaranteed (VG) mode during conventional ventilation. To analyze the impact of leakage around the endotracheal tube and the set maximum allowed inflating pressure (Pmax). Design: Prospective multicenter observational study. Methods: Clinical and ventilator data were collected from 71 infants receiving VG ventilation for ≥12 h in four neonatal intensive care units (NICUs). Ventilator settings, parameters, and alarms were downloaded with 0.5 Hz sampling rate. Results: Data from 4,341 h of ventilation were analyzed. The median (interquartile range, IQR) of the absolute difference between the target and measured expired tidal volume was 0.76 (0.51–1.16) mL/kg. It was less when leak was <50% (median 0.36, IQR: 0.25–0.64 mL/kg, p <.001) and even less when the required peak inflating pressure (PIP) was also below Pmax (median: 0.09 mL/kg, IQR: 0.00–0.16 mL/kg, p <.001). On NICUs setting Pmax higher, tidal volume was maintained significantly closer to target. In 56 patients VG was continued until extubation. Two ventilator malfunctions were reported, none of them resulting in patient harm. “Tidal volume not reached” alarm occurred 32 times hourly, usually lasting for <10 s. Conclusion: The fabian HFOi ventilator maintains tidal volume close to its target, particularly when leak is <50% and when PIP is below Pmax. In most patients VG can be continued until extubation. Despite frequent ventilator alarms, ventilator malfunctions occur very rarely.