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Conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): a UK multicentre, open, parallel-group, randomised clinical trial

Peters MJ 1 , Gould DW 2 , Ray S 3 , Thomas K 2 , Chang I 2 , Orzol M 2 Show all authors , O'Neill L 3 , Agbeko R 4 , Au C 2 , Draper E 5 , Elliot-Major L 6 , Giallongo E 2 , Jones GAL 3 , Lampro L 2 , Lillie J 7 , Pappachan J 8 , Peters S 2 , Ramnarayan P 9 , Sadique Z 10 , Rowan KM 2 , Harrison DA 2 , Mouncey PR 2 , Oxy-PICU Investigators of the Paediatric Critical Care Society Study Group (PCCS-SG)

Affiliations 

  • 1 Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust and NIHR Biomedical Research Centre, London, UK; Respiratory, Critical Care and Anaesthesia Unit, Infection, Inflammation, and Immunity Division, University College London Great Ormond Street Institute of Child Health, London, UK; Children's Acute Transport Service, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK. Electronic address: mark.peters@ucl.ac.uk
  • 2 Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, UK
  • 3 Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust and NIHR Biomedical Research Centre, London, UK
  • 4 Department of Paediatric Intensive Care, Great North Children's Hospital, The Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK
  • 5 Department of Population Health Sciences, University of Leicester, Leicester, UK
  • 6 Parent representative, London, UK
  • 7 Paediatric Intensive Care Unit, Evelina London Children's Hospital, London, UK; Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK
  • 8 Paediatric Intensive Care Unit, University Hospital Southampton NHS Foundation Trust, Southampton, UK
  • 9 Children's Acute Transport Service, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK; Section of Anaesthetics, Pain Medicine, and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK
  • 10 Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK
Lancet, 2024 Jan 27;403(10424):355-364.
PMID: 38048787 DOI: 10.1016/S0140-6736(23)01968-2

Abstract

BACKGROUND: The optimal target for systemic oxygenation in critically ill children is unknown. Liberal oxygenation is widely practiced, but has been associated with harm in paediatric patients. We aimed to evaluate whether conservative oxygenation would reduce duration of organ support or incidence of death compared to standard care.

METHODS: Oxy-PICU was a pragmatic, multicentre, open-label, randomised controlled trial in 15 UK paediatric intensive care units (PICUs). Children admitted as an emergency, who were older than 38 weeks corrected gestational age and younger than 16 years receiving invasive ventilation and supplemental oxygen were randomly allocated in a 1:1 ratio via a concealed, central, web-based randomisation system to conservative peripheral oxygen saturations ([SpO2] 88-92%) or liberal (SpO2 >94%) targets. The primary outcome was the duration of organ support at 30 days following random allocation, a rank-based endpoint with death either on or before day 30 as the worst outcome (a score equating to 31 days of organ support), with survivors assigned a score between 1 and 30 depending on the number of calendar days of organ support received. The primary effect estimate was the probabilistic index, a value greater than 0·5 indicating more than 50% probability that conservative oxygenation is superior to liberal oxygenation for a randomly selected patient. All participants in whom consent was available were included in the intention-to-treat analysis. The completed study was registered with the ISRCTN registry (ISRCTN92103439).

FINDINGS: Between Sept 1, 2020, and May 15, 2022, 2040 children were randomly allocated to conservative or liberal oxygenation groups. Consent was available for 1872 (92%) of 2040 children. The conservative oxygenation group comprised 939 children (528 [57%] of 927 were female and 399 [43%] of 927 were male) and the liberal oxygenation group included 933 children (511 [56%] of 920 were female and 409 [45%] of 920 were male). Duration of organ support or death in the first 30 days was significantly lower in the conservative oxygenation group (probabilistic index 0·53, 95% CI 0·50-0·55; p=0·04 Wilcoxon rank-sum test, adjusted odds ratio 0·84 [95% CI 0·72-0·99]). Prespecified adverse events were reported in 24 (3%) of 939 patients in the conservative oxygenation group and 36 (4%) of 933 patients in the liberal oxygenation group.

INTERPRETATION: Among invasively ventilated children who were admitted as an emergency to a PICU receiving supplemental oxygen, a conservative oxygenation target resulted in a small, but significant, greater probability of a better outcome in terms of duration of organ support at 30 days or death when compared with a liberal oxygenation target. Widespread adoption of a conservative oxygenation saturation target (SpO2 88-92%) could help improve outcomes and reduce costs for the sickest children admitted to PICUs.

FUNDING: UK National Institute for Health and Care Research Health Technology Assessment Programme.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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