Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study)

Abstract

ObjectiveThis study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2).DesignMulticentre randomised cross-over study.SettingFive neonatal intensive care units experienced with automated control of FiO2and the fabian ventilator.Patients39 infants: median gestational age of 27 weeks (IQR: 26–30), postnatal age 7 days (IQR: 2–17), weight 1120 g (IQR: 915–1588), FiO20.32 (IQR: 0.22–0.43) receiving both non-invasive (27) and invasive (12) respiratory support.InterventionRandomised sequential 24-hour periods of automated and manual FiO2control.Main outcome measuresProportion (%) of time in normoxaemia (90%–95% with FiO2>0.21 and 90%–100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2extremes.ResultsDuring automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO2>0.21 (16%±19% vs 35%±24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%–3.5%) vs 5% (1%–10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO2were consistent with the times at extremes.ConclusionsThis study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.