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Comparison of two different oxygen saturation target ranges for automated oxygen control in preterm infants: a randomised cross-over trial
  1. Fleur Brouwer,
  2. Hylke H Salverda,
  3. Sophie J E Cramer,
  4. Chantal Schmeits,
  5. Jacoline van der Plas,
  6. Arjan B te Pas,
  7. Janneke Dekker
  1. Willem-Alexander Children's Hospital, Department of Paediatrics, Division of Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
  1. Correspondence to Mrs. Fleur Brouwer, Department of Neonatology, Leiden University Medical Center, Leiden, Netherlands; f.brouwer{at}lumc.nl

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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Data availability statement

Data are available on reasonable request.

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Footnotes

  • FB and HHS are joint first authors.

  • Contributors FB: collected the data (with HS and JD), compiled the data (with HHS, SJEC, JvdP, CS and JD), analysed the data (with HHS and JD), interpreted the data (with JD), wrote the first draft of the manuscript and approved the final version of the manuscript. HHS: co-conceived the study (with ABtP and JD), conducted the study (with JD), collected the data (with FB and JD), compiled the data (with FB, SJEC, JvdP, CS and JD), analysed the data (with FB and JD), reviewed and edited the manuscript and approved the final version of the manuscript. SJEC: compiled the data (with FB, HHS, JvdP, CS and JD), reviewed and edited the manuscript and approved the final version of the manuscript. JvdP and CS: compiled the data (with FB, HHS, SJEC and JD), reviewed the manuscript and approved the final version of the manuscript. ABtP: co-conceived the study (with HHS and JD), had full responsibility for the conduct of the study, had access to the data, reviewed and edited the manuscript and approved the final version of the manuscript.

    JD: co-conceived the study (with HHS and ABtP), oversaw the study conduct, conducted the study (with HHS), collected the data (with FB and HHS), compiled the data (with FB, HHS, SJEC, JvdP and CS), interpreted the data (with FB), reviewed and edited the manuscript and approved the final version of the manuscript.

  • Funding This work was supported by Inspiration Healthcare by an unrestricted research grant.

  • Disclaimer Inspiration Healthcare had no role in study design nor in the collection, analysis and interpretation of data, writing of the report and decision to submit the paper for publication.

  • Competing interests ABtP has received an unrestricted research grant from Inspiration Healthcare.

  • Provenance and peer review Not commissioned; internally peer reviewed.