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Intensive Care Medicine

, Volume 44, Issue 8, pp 1240–1248 | Cite as

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

  • 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)
Pediatric Original

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.

Keywords

PICU respiratory failure Oxygenation Clinical trial 

Notes

Acknowledgements

The authors would like to thank the medical and nursing staff at each trial site, the Paediatric Intensive Care Society Study Group, and the patients and their families who contributed to this study. We are also grateful to members of the Trial Steering Committee and Data Monitoring Committee for their assistance in performing this study.

Funding

This study was funded by Great Ormond Street Hospital Children’s Charity. Registered Charity No. 235825 and supported by the National Institute for Health Research Great Ormond Street Hospital Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the UK Department of Health.

Compliance with ethical standards

Conflicts of interest

No conflicts of interest to declare.

Supplementary material

134_2018_5232_MOESM1_ESM.docx (491 kb)
Supplementary material 1 (DOCX 491 kb)
134_2018_5232_MOESM2_ESM.doc (218 kb)
Supplementary material 2 (DOC 217 kb)
134_2018_5232_MOESM3_ESM.pdf (532 kb)
Supplementary material 3 (PDF 532 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature and ESICM 2018

Authors and Affiliations

  • Mark J. Peters
    • 1
    • 2
  • Gareth A. L. Jones
    • 1
    • 2
  • Daisy Wiley
    • 3
  • Jerome Wulff
    • 3
  • Padmanabhan Ramnarayan
    • 4
    • 5
  • Samiran Ray
    • 2
  • David Inwald
    • 5
  • Michael Grocott
    • 6
  • Michael Griksaitis
    • 7
    • 9
  • John Pappachan
    • 7
    • 9
  • Lauran O’Neill
    • 2
  • Simon Eaton
    • 8
  • Paul R. Mouncey
    • 3
  • David A. Harrison
    • 3
  • Kathryn M. Rowan
    • 3
  • The Oxy-PICU Investigators for the Paediatric Intensive Care Society Study Group (PICS-SG)
  1. 1.Respiratory Critical Care and Anaesthesia UnitUCL Great Ormond Street Institute of Child HealthLondonUK
  2. 2.Paediatric Intensive Care UnitGreat Ormond Street HospitalLondonUK
  3. 3.Clinical Trials UnitIntensive Care National Audit and Research Centre (ICNARC)LondonUK
  4. 4.Children’s Acute Transport ServiceGreat Ormond Street HospitalLondonUK
  5. 5.Paediatric Intensive Care UnitSt Mary’s Hospital, Imperial College Healthcare NHS TrustLondonUK
  6. 6.Clinical and Experimental Sciences, Faculty of MedicineUniversity of SouthamptonSouthamptonUK
  7. 7.Paediatric Intensive Care Unit, Southampton Children’s HospitalUniversity Hospital Southampton NHS Foundation TrustSouthamptonUK
  8. 8.Stem Cells and Regenerative Medicine SectionUCL Great Ormond Street Institute of Child HealthLondonUK
  9. 9.The NIHR Biomedical Biomedical Research CentreSouthamptonUK

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