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

Abstract

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