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

To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.

Randomised cross-over study.

Tertiary level neonatal unit in the Netherlands.

Preterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO₂) 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.

Inspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO₂ controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant.

Time spent within set SpO₂ TR (91%-95% with supplemental oxygen and 91%-100% without supplemental oxygen).

Time spent within the SpO₂ 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 SpO₂ <80% (0.5 (0.1-1.0)% vs 0.2 (0.1-0.4)%, p=0.061). Long-lasting SpO₂ deviations occurred less frequently during OxyGenie control.

The OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO₂ <80%), although at the cost of a small increase in mild hypoxaemia.

NCT03877198.