Comparison of two different oxygen saturation target ranges for automated oxygen control in preterm infants: a randomised cross-over trial.

OBJECTIVE: To compare the effect of peripheral oxygen saturation (SpO2 ) target range (TR) (either 91%-95% and 92%-96%) on the frequency and duration of hypoxic and hyperoxic episodes while on automated oxygen control using the OxyGenie controller.

DESIGN: Randomised cross-over study.

SETTING: Tertiary-level neonatal unit in the Netherlands.

PATIENTS: Infants (n=27) with a median (IQR) gestational age of 27+0 (25+5-27+3) weeks and postnatal age of 16 (10-22) days, receiving invasive or non-invasive respiratory support.

INTERVENTIONS: In both groups supplemental oxygen was titrated to a TR of 91%-95% (TRlow ) or 92%-96% (TRhigh ) by the OxyGenie controller (SLE6000 ventilator) for 24 hours each, in random sequence. After a switch in TR, a 1-hour washout period was applied to prevent carry-over bias.

MAIN OUTCOME MEASURES: Frequency and duration of hypoxic (SpO2 <80% for ≥1 s) and hyperoxic episodes (SpO2 >98% for ≥1 s).

RESULTS: Hypoxic episodes were less frequent when the higher range was targeted (TRhigh vs TRlow : 2.5 (0.7-6.2)/hour vs 2.4 (0.9-10.2)/hour, p=0.02), but hyperoxic episodes were more frequent (5.3 (1.8-12.3)/hour vs 2.9 (1.0-7.1)/hour, p<0.001). The duration of the out-of-range episodes was not significantly different (hypoxia: 4.7 (2.8-7.1) s vs 4.4 (3.7-6.5) s, p=0.67; hyperoxia: 4.3 (3.3-4.9) s vs 3.9 (2.8-5.5) s, p=0.89).

CONCLUSION: Targeting a higher SpO2 TR with the OxyGenie controller reduced hypoxic episodes but increased hyperoxic episodes. This study highlights the feasibility of using an automated oxygen titration device to explore the effects of subtle TR adjustments on clinical outcomes in neonatal care.

TRIAL REGISTRATION NUMBER: NL9662.