Conservative versus conventional oxygenation target in children admitted in PICU: a randomized controlled trial

The objective of this study is to compare conservative versus conventional oxygen saturation targets on clinical outcomes in critically ill children requiring respiratory support. This open label randomized controlled trial was conducted in a tertiary care pediatric intensive care unit between May 2023 and November 2024. Children aged 1 month to 15 years requiring invasive or noninvasive oxygen therapy were randomized to conservative (SpO₂ 88-92%) or conventional (SpO₂ 94-99%) oxygen saturation targets. Fraction of inspired oxygen was titrated to maintain assigned targets. The primary outcome was a composite of death and organ support at 30 days. Secondary outcomes included mortality at 7 and 30 days, duration of respiratory support and oxygen therapy, length of PICU and hospital stay, and oxidative stress assessed by serum malondialdehyde (MDA) at baseline and day 7. A total of 178 children were randomized. Baseline characteristics and illness severity were comparable between groups. The median composite outcome score was 8 (IQR 4-20.25) in the conservative group and 10 (IQR 5-20) in the conventional group (p = 0.15). Duration of respiratory support (4 vs 6 days; p = 0.003) and oxygen therapy (8 vs 100 h; p < 0.001) were significantly lower in the conservative group. Mortality at 7 and 30 days, organ support days, length of stay, and MDA levels were similar.Conclusion: Conservative oxygen saturation targets (88-92%) were safe and resulted in similar mortality and organ dysfunction compared with conventional targets, with reduced duration of respiratory support and oxygen therapy. Larger multicenter trials are needed to confirm these findings.Trial registration: The trial is registered in Clinical Trial Registry India (CTRI) (registration number CTRI/2023/11/060105, date of registration 21/11/2023.