Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial

OBJECTIVE: To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes. DESIGN: Randomised cross-over study. SETTING: Tertiary level neonatal unit in the Netherlands. PATIENTS: Preterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO(2)) TR of 91%–95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days–27 weeks 6 days) and postnatal age 19 (IQR 17–24) days. INTERVENTIONS: Inspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO(2) controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant. MAIN OUTCOME MEASURES: Time spent within set SpO(2) TR (91%–95% with supplemental oxygen and 91%–100% without supplemental oxygen). RESULTS: Time spent within the SpO(2) TR was higher during OxyGenie control (80.2 (72.6–82.4)% vs 68.5 (56.7–79.3)%, p<0.005). Less time was spent above TR while in supplemental oxygen (6.3 (5.1–9.9)% vs 15.9 (11.5–30.7)%, p<0.005) but more time spent below TR during OxyGenie control (14.7 (11.8%–17.2%) vs 9.3 (8.2–12.6)%, p<0.05). There was no significant difference in time with SpO(2) <80% (0.5 (0.1–1.0)% vs 0.2 (0.1–0.4)%, p=0.061). Long-lasting SpO(2) deviations occurred less frequently during OxyGenie control. CONCLUSIONS: The OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO(2) <80%), although at the cost of a small increase in mild hypoxaemia. TRIAL REGISTRY NUMBER: NCT03877198