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

OBJECTIVE

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 (FiO).

DESIGN

Multicentre randomised cross-over study.

SETTING

Five neonatal intensive care units experienced with automated control of FiO and the fabian ventilator.

PATIENTS

39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support.

INTERVENTION

Randomised sequential 24-hour periods of automated and manual FiO control.

MAIN OUTCOME MEASURES

Proportion (%) of time in normoxaemia (90%-95% with FiO>0.21 and 90%-100% when FiO=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO>0.21) and prevalence of episodes ≥60 s at these two SpO extremes.

RESULTS

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 FiO>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 SpO were consistent with the times at extremes.

CONCLUSIONS

This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.