Protocol for a randomized multiple center trial of conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): oxygen in pediatric intensive care
Author(s)
Type
Journal Article
Abstract
OBJECTIVES:
Oxygen administration is a fundamental part of pediatric critical care, with supplemental oxygen offered to nearly every acutely unwell child. However, optimal targets for systemic oxygenation are unknown. Oxy-PICU aims to evaluate the clinical effectiveness and cost-effectiveness of a conservative peripheral oxygen saturation (Spo2) target of 88–92% compared with a liberal target of more than 94%.
DESIGN:
Pragmatic, open, multiple-center, parallel group randomized control trial with integrated economic evaluation.
SETTING:
Fifteen PICUs across England, Wales, and Scotland.
PATIENTS:
Infants and children age more than 38 week-corrected gestational age to 16 years who are accepted to a participating PICU as an unplanned admission and receiving invasive mechanical ventilation with supplemental oxygen for abnormal gas exchange.
INTERVENTION:
Adjustment of ventilation and inspired oxygen settings to achieve an Spo2 target of 88–92% during invasive mechanical ventilation.
MEASUREMENTS and MAIN RESULTS:
Randomization is 1:1 to a liberal Spo2 target of more than 94% or a conservative Spo2 target of 88–92% (inclusive), using minimization with a random component. Minimization will be performed on: age, site, primary reason for admission, and severity of abnormality of gas exchange. Due to the emergency nature of the treatment, approaching patients for written informed consent will be deferred to after randomization. The primary clinical outcome is a composite of death and days of organ support at 30 days. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support, and discharge outcomes. This trial received Health Research Authority approval on December 23, 2019 (reference: 272768), including a favorable ethical opinion from the East of England—Cambridge South Research Ethics Committee (reference number: 19/EE/0362). Trial findings will be disseminated in national and international conferences and peer-reviewed journals.
Oxygen administration is a fundamental part of pediatric critical care, with supplemental oxygen offered to nearly every acutely unwell child. However, optimal targets for systemic oxygenation are unknown. Oxy-PICU aims to evaluate the clinical effectiveness and cost-effectiveness of a conservative peripheral oxygen saturation (Spo2) target of 88–92% compared with a liberal target of more than 94%.
DESIGN:
Pragmatic, open, multiple-center, parallel group randomized control trial with integrated economic evaluation.
SETTING:
Fifteen PICUs across England, Wales, and Scotland.
PATIENTS:
Infants and children age more than 38 week-corrected gestational age to 16 years who are accepted to a participating PICU as an unplanned admission and receiving invasive mechanical ventilation with supplemental oxygen for abnormal gas exchange.
INTERVENTION:
Adjustment of ventilation and inspired oxygen settings to achieve an Spo2 target of 88–92% during invasive mechanical ventilation.
MEASUREMENTS and MAIN RESULTS:
Randomization is 1:1 to a liberal Spo2 target of more than 94% or a conservative Spo2 target of 88–92% (inclusive), using minimization with a random component. Minimization will be performed on: age, site, primary reason for admission, and severity of abnormality of gas exchange. Due to the emergency nature of the treatment, approaching patients for written informed consent will be deferred to after randomization. The primary clinical outcome is a composite of death and days of organ support at 30 days. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support, and discharge outcomes. This trial received Health Research Authority approval on December 23, 2019 (reference: 272768), including a favorable ethical opinion from the East of England—Cambridge South Research Ethics Committee (reference number: 19/EE/0362). Trial findings will be disseminated in national and international conferences and peer-reviewed journals.
Date Issued
2022-09-01
Date Acceptance
2022-08-01
Citation
Pediatric Critical Care Medicine, 2022, 23 (9), pp.736-744
ISSN
1529-7535
Publisher
Lippincott, Williams & Wilkins
Start Page
736
End Page
744
Journal / Book Title
Pediatric Critical Care Medicine
Volume
23
Issue
9
Copyright Statement
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/35699737
PII: 00130478-202209000-00008
Subjects
child
critical care
Critical Care Medicine
General & Internal Medicine
hyperoxia
hypoxia
Life Sciences & Biomedicine
mechanical ventilation
MODEL
MORTALITY
oxygen saturation
Pediatrics
Science & Technology
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2022-09-01