{Reference Type}: Journal Article
{Title}: Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study).
{Author}: Wilinska M;Bachman T;Szczapa T;Wroblewska-Seniuk K;Chojnacka K;Loniewska B;Olszanska K;Rzepecka Weglarz B;Janusz K;Piwowarczyk P;Onland W;Hutten GJ;van Leuteren RW;van Kaam AH;
{Journal}: BMJ Paediatr Open
{Volume}: 8
{Issue}: 1
{Year}: 2024 Jul 16
{Factor}: 2.926
{DOI}: 10.1136/bmjpo-2024-002583
{Abstract}: <B>OBJECTIVE: </B>This 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).<BR><B>METHODS: </B>Multicentre randomised cross-over study.<BR><B>METHODS: </B>Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator.<BR><B>METHODS: </B>39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO2 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support.<BR><B>METHODS: </B>Randomised sequential 24-hour periods of automated and manual FiO2 control.<BR><B>METHODS: </B>Proportion (%) 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 SpO2 extremes.<BR><B>RESULTS: </B>During 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 SpO2 were consistent with the times at extremes.<BR><B>CONCLUSIONS: </B>This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.