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04.06.2018 | Pediatric Original

Conservative versus liberal oxygenation targets in critically ill children: the randomised multiple-centre pilot Oxy-PICU trial

verfasst von: Mark J. Peters, Gareth A. L. Jones, Daisy Wiley, Jerome Wulff, Padmanabhan Ramnarayan, Samiran Ray, David Inwald, Michael Grocott, Michael Griksaitis, John Pappachan, Lauran O’Neill, Simon Eaton, Paul R. Mouncey, David A. Harrison, Kathryn M. Rowan, The Oxy-PICU Investigators for the Paediatric Intensive Care Society Study Group (PICS-SG)

Erschienen in: Intensive Care Medicine | Ausgabe 8/2018

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Abstract

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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Titel: Conservative versus liberal oxygenation targets in critically ill children: the randomised multiple-centre pilot Oxy-PICU trial
verfasst von: Mark J. Peters
Gareth A. L. Jones
Daisy Wiley
Jerome Wulff
Padmanabhan Ramnarayan
Samiran Ray
David Inwald
Michael Grocott
Michael Griksaitis
John Pappachan
Lauran O’Neill
Simon Eaton
Paul R. Mouncey
David A. Harrison
Kathryn M. Rowan
The Oxy-PICU Investigators for the Paediatric Intensive Care Society Study Group (PICS-SG)
Publikationsdatum: 04.06.2018
Verlag: Springer Berlin Heidelberg
Erschienen in: Intensive Care Medicine / Ausgabe 8/2018
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-018-5232-7

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Conservative versus liberal oxygenation targets in critically ill children: the randomised multiple-centre pilot Oxy-PICU trial