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Published on: October 25, 2017
Conservative versus liberal oxygenation targets in critically ill children: the randomised multiple-centre pilot
Mark J Peters1,2, Gareth A L Jones3,4, Daisy Wiley5
1Respiratory Critical Care and Anaesthesia Unit, UCL Great Ormond Street Institute of Child Health, London, WC1N 1EH, UK. mark.peters@ucl.ac.uk.
Insights
This study found that a conservative oxygen saturation target (88-92%) is feasible for critically ill children, with no significant difference in outcomes compared to a liberal target (>94%). Further trials on optimal oxygen saturation levels in pediatric intensive care are warranted.
Area of Science:
- Pediatric Critical Care Medicine
- Respiratory Physiology
- Clinical Trial Design
Background:
- Oxygen saturation (SpO2) monitoring is standard for children on respiratory support.
- No randomized trials have compared SpO2 targets in critically ill children.
- High SpO2 targets (>94%) may pose risks outweighing benefits.
Purpose of the Study:
- To assess the feasibility of a randomized clinical trial comparing conservative versus liberal oxygenation targets in critically ill children.
- To evaluate recruitment rates, protocol adherence, and safety of different SpO2 targets.
Main Methods:
- An open, parallel-group randomized trial was conducted in three pediatric intensive care units.
- Children aged 38 weeks gestation to 16 years receiving respiratory support were assigned to conservative (SpO2 88-92%) or liberal (SpO2 >94%) groups.
- A 'research without prior consent' approach was used, with subsequent consent sought.
Main Results:
- 119 children were randomized, achieving a recruitment rate of 10 patients/month/site.
- The conservative group had a median SpO2 of 94.9% and the liberal group 97.5%.
- No significant differences were observed in length of stay, organ support, or mortality; two cardiac arrests occurred in the liberal group.
Conclusions:
- A definitive clinical trial on peripheral oxygen saturation targets in critically ill children is feasible.
- The study demonstrated successful recruitment and adherence for comparing SpO2 targets.
- Further research is needed to establish optimal SpO2 targets for pediatric intensive care.
Background:
Oxygen saturation monitoring for children receiving respiratory support is standard worldwide. No randomised clinical trials have compared peripheral oxygen saturation (SpO2) targets for critically ill children. The harm of interventions to raise SpO2 to > 94% may exceed their benefits.
Methods:
We undertook an open, parallel-group randomised trial of children > 38 weeks completed gestation and < 16 years of age receiving invasive or non-invasive respiratory support and supplemental oxygen who were admitted urgently to one of three paediatric intensive care units. A 'research without prior consent' approach was employed. Children were randomly assigned to a liberal oxygenation group (SpO2 targets > 94%) or a conservative oxygenation group (SpO2 = 88-92% inclusive). Outcomes were measures of feasibility: recruitment rate, protocol adherence and acceptability, between-group separation of SpO2 and safety. The Oxy-PICU trial was registered before recruitment: ClinicalTrials.gov identifier NCT03040570.
Results:
A total of 159 children met the inclusion criteria, of whom 119 (75%) were randomised between April and July 2017, representing a rate of 10 patients per month per site. The mean time to randomisation from first contact with an intensive care team was 1.9 (SD 2.2) h. Consent to continue in the study was obtained in 107 cases (90%); the children's parents/legal representatives were supportive of the consent process. The median (interquartile range, IQR) of time-weighted individual mean SpO2 was 94.9% (92.6-97.1) in the conservative oxygenation group and 97.5% (96.2-98.4) in the liberal group [difference 2.7%, 95% confidence interval (95% CI) 1.3-4.0%, p < 0.001]. Median (IQR) time-weighted individual mean FiO2 was 0.28 (0.24-0.37) in the conservative group and 0.37 (0.30-0.42) in the liberal group (difference 0.08, 95% CI 0.03-0.13, p < 0.001). There were no significant between-group differences in length of stay, duration of organ support or mortality. Two prespecified serious adverse events (cardiac arrests) occurred, both in the liberal oxygenation group.
Conclusion:
A definitive clinical trial of peripheral oxygen saturation targets is feasible in critically ill children.
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