Conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): a UK multicentre, open,
Mark J Peters1, Doug W Gould2, Samiran Ray3
1Paediatric 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.
Insights
A conservative oxygenation target (SpO2 88-92%) in critically ill children significantly reduced organ support duration or death compared to liberal targets. This finding suggests improved outcomes for children in pediatric intensive care units (PICUs).
Area of Science:
- Pediatric Critical Care Medicine
- Respiratory Physiology
- Clinical Trial Design
Background:
- Optimal systemic oxygenation targets in critically ill children remain unclear.
- Liberal oxygenation, while common, may pose risks to pediatric patients.
- This study evaluated conservative oxygenation versus standard care to reduce organ support and mortality.
Purpose of the Study:
- To compare conservative oxygenation (SpO2 88-92%) with liberal oxygenation (SpO2 >94%) in invasively ventilated children.
- To determine if a conservative approach reduces the duration of organ support or incidence of death within 30 days.
- To assess the safety and efficacy of different oxygenation strategies in pediatric intensive care units (PICUs).
Main Methods:
- A pragmatic, multicenter, randomized controlled trial (Oxy-PICU) involving 15 UK PICUs.
- 2040 children receiving invasive ventilation and supplemental oxygen were randomized (1:1) to conservative or liberal oxygen targets.
- The primary outcome was a rank-based measure of organ support duration or death at 30 days, analyzed using intention-to-treat.
Main Results:
- A conservative oxygenation target demonstrated a statistically significant improvement in outcomes (probabilistic index 0.53, p=0.04).
- The conservative group showed a reduced duration of organ support or death compared to the liberal group (adjusted odds ratio 0.84).
- Adverse events were slightly lower in the conservative group (3%) compared to the liberal group (4%).
Conclusions:
- A conservative oxygenation target (SpO2 88-92%) significantly improves outcomes for invasively ventilated children in PICUs.
- This strategy offers a greater probability of reduced organ support duration and mortality.
- Widespread adoption of conservative oxygen targets could enhance patient outcomes and reduce healthcare costs.
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.
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