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

Abstract

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.

  • respiratory medicine
  • neonatology
  • technology

Data availability statement

Data are available on reasonable request.

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