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Protocol for a randomised pilot multiple centre trial of conservative versus liberal oxygenation targets in
Gareth A L Jones1,2, Padmanabhan Ramnarayan3,4, Sainath Raman2
1Respiratory Critical Care and Anaesthesia Unit, UCL Great Ormond Street Institute of Child Health, London, UK.
Insights
This pilot study assesses the feasibility of a randomized trial on oxygenation targets in critically ill children. It compares conservative (88%-92%) versus liberal (>94%) peripheral oxygen saturation (SpO2) levels to guide future research.
Area of Science:
- Pediatric Critical Care Medicine
- Respiratory Physiology
- Clinical Trial Design
Background:
- Optimal systemic oxygenation targets in pediatric critical illness remain undefined.
- High arterial oxygenation is linked to adverse outcomes in neonates and adults.
- Current pediatric intensive care unit (PICU) practices for oxygenation vary, often targeting SpO2 >95%.
Purpose of the Study:
- To determine the feasibility of a randomized controlled trial (RCT) in critically ill children.
- To compare a conservative SpO2 target range (88%-92%) against a liberal SpO2 target (>94%).
- To inform future definitive trials on optimal oxygenation strategies in pediatric critical care.
Main Methods:
- Pragmatic, open-label, pilot randomized controlled trial (Oxy-PICU).
- Inclusion of infants and children requiring mechanical ventilation with abnormal gas exchange.
- Randomization to either a conservative SpO2 target (88%-92%) or a liberal SpO2 target (>94%).
- Primary feasibility outcome: adequate study recruitment (target: 120 participants).
- Secondary data collection: demographics, clinical status, oxygenation, organ support, discharge outcomes, and oxidative stress markers.
Main Results:
- Feasibility outcomes are yet to be determined as this is a pilot study.
- Recruitment rates and adherence to target SpO2 ranges will be key indicators of feasibility.
- Biochemical markers of oxidative stress will be analyzed.
Conclusions:
- This pilot study is crucial for establishing the methodology for a larger RCT.
- Findings will guide the optimal oxygenation strategy for critically ill children.
- The study aims to reduce mortality and morbidity associated with suboptimal oxygenation in pediatric intensive care.
Introduction:
Optimal targets for systemic oxygenation in paediatric critical illness are unknown. Observational data indicate that high levels of arterial oxygenation are associated with poor outcomes in resuscitation of the newborn and in adult critical illness. Within paediatric intensive care units (PICUs), staff prevent severe hypoxia wherever possible, but beyond this there is no consensus. Practice varies widely with age, diagnosis, treating doctor and local or national guidelines followed, though peripheral blood oxygen saturations (SpO2) of >95% are often targeted. The overall aim of this pilot study is to determine the feasibility of performing a randomised trial in critically ill children comparing current practice of liberal SpO2 targets with a more conservative target.
Methods And Analysis:
Oxy-PICU is a pragmatic, open, pilot randomised controlled trial in infants and children requiring mechanical ventilation and receiving supplemental oxygen for abnormal gas exchange accepted for emergency admission to one of three participating UK PICUs. The study groups will be either a conservative SpO2 target of 88%-92% (inclusive) or a liberal SpO2 target of >94%. Infants and children who fulfil all inclusion criteria and none of the exclusion criteria will be randomised 1:1 by a secure web-based system to one of the two groups. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support. Discharge outcomes will also be recorded. In addition to observational data, blood and urine samples will be taken to identify biochemical markers of oxidative stress. Outcomes are targeted at assessing study feasibility with a primary outcome of adequate study recruitment (target: 120 participants).
Ethics And Dissemination:
The trial received Health Research Authority approval on 1 June 2017 (16/SC/0617). Study findings will be disseminated in national and international conferences and peer-reviewed journals.
Trial Registration Number:
NCT03040570.
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