Conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): a UK multicentre, open, parallel-group, randomised clinical trial.
Journal
Lancet (London, England)
ISSN: 1474-547X
Titre abrégé: Lancet
Pays: England
ID NLM: 2985213R
Informations de publication
Date de publication:
01 Dec 2023
01 Dec 2023
Historique:
received:
22
07
2023
revised:
10
09
2023
accepted:
14
09
2023
medline:
5
12
2023
pubmed:
5
12
2023
entrez:
4
12
2023
Statut:
aheadofprint
Résumé
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. 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 ([SpO 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. 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 (SpO UK National Institute for Health and Care Research Health Technology Assessment Programme.
Sections du résumé
BACKGROUND
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
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 ([SpO
FINDINGS
RESULTS
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
CONCLUSIONS
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 (SpO
FUNDING
BACKGROUND
UK National Institute for Health and Care Research Health Technology Assessment Programme.
Identifiants
pubmed: 38048787
pii: S0140-6736(23)01968-2
doi: 10.1016/S0140-6736(23)01968-2
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Carla Thomas
(C)
Petr Jirasek
(P)
Dawn Jones
(D)
Rachael Dore
(R)
Laura O'Malley
(L)
Hari Krishnan Kanthimatinathan
(HK)
Helen Winmill
(H)
Lydia Ashton
(L)
Samantha Owen
(S)
Peter Davis
(P)
Helen Marley-Munn
(H)
Francesca Moody
(F)
Ellen Haskins
(E)
Laura Dodge
(L)
Andrew Jones
(A)
Joan Thomas
(J)
Gail Murphy
(G)
Jon Lillie
(J)
Aleks Williams
(A)
Paul Wellman
(P)
Esther Aougah
(E)
Caroline Payne
(C)
Holly Belfield
(H)
Joshua Akpan
(J)
Sarah Benkenstein
(S)
Emily Beech
(E)
Ilham I Manjra
(II)
Sara-Louise Hulme
(SL)
Avishay Sarfatti
(A)
Kirsten Beadon
(K)
Rebecca Harmer
(R)
Akash Deep
(A)
Christina Balnta
(C)
Pamela D'Silva
(P)
Asha Hylton
(A)
Bedangshu Saikia
(B)
Sanjiv Nichani
(S)
Rekha Patel
(R)
Patrick Davies
(P)
Laura Anderson
(L)
Laura Lawless
(L)
Alex Dewar
(A)
David Reynolds
(D)
Richard Levin
(R)
Fiona Bowman
(F)
Andrea-Rosa Pujazon
(AR)
Mark Davidson
(M)
Katarzyna Szulik
(K)
Lara Bunni
(L)
Claire Jennings
(C)
Rebecca Marshall
(R)
Michael Griksaitis
(M)
Philippa Thomas
(P)
Catherine Postlethwaite
(C)
Amber Cook
(A)
Buvana Dwarakanathan
(B)
Joana Gomes de Queiroz
(J)
Montserrat Ros Foguet
(M)
Hawakiin Ali
(H)
Thomas Bycroft
(T)
Sarah Darnell
(S)
Sobia Mustafa
(S)
Katy Bridges
(K)
Kirsty Mulgrew
(K)
Nadine Heenan
(N)
Lynne Bell
(L)
Andrew Davies
(A)
Informations de copyright
Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests All authors report funding from the National Institute for Health and Social Care Research (NIHR) Health Technology Assessment Programme to their institutions for the work presented in the manuscript. SR reports funding to their institution from UK Engineering and Physical Science Research Council, and consulting fees, honoraria, and travel fees from Roche and the Malaysian Society of Intensive Care during the study period. KMR is Director of the NIHR Health and Social Care Delivery Research Programme. All other authors declare no competing interests.