This study is no longer recruiting participants.

Background

Of the thousands of seriously ill children referred to intensive care as an emergency in the UK each year, around 75% receive both invasive mechanical ventilation and supplemental oxygen. However, the optimal targets for systemic oxygenation are unknown.  Current practice is generally to administer supplemental oxygen to achieve arterial oxygen saturations that are at, or above, the normal healthy range.

However, observational data suggest harm from too generous use of supplemental oxygen in adults and children. There is no high-quality evidence from randomised controlled trial (RCT) data to support and guide clinicians’ use of oxygen.  Therefore, there is an urgent need for high quality evidence to inform the choice of oxygen saturation targets in the most seriously unwell children.

Design

The Oxy-PICU study therefore aims to determine if the risks of interventions employed on intensive care to raise peripheral oxygen saturation to >94% exceed their benefits when compared to a peripheral oxygen saturation of 88-92%. All objectives evaluate the clinical and cost effectiveness of a conservative peripheral SpO2 target of 88-92%.

Results from this study will have a large and immediate impact on paediatric ICU clinical practice and on patient outcomes throughout the NHS.



Key information

Chief investigator(s)

Professor Mark Peters, Great Ormond Street Hospital for Children NHS Foundation Trust

Sponsor

Intensive Care National Audit & Research Centre (ICNARC)

Funder

National Institute for Health and Care Research (NIHR) – Health Technology Assessment (HTA) Programme

(Project Number: NIHR 127547)

Trial registration(s)

ISRCTN Registry: ISRCTN92103439

IRAS Number: 272768

Contact information

Trial manager: Irene Chang

Email: OxyPICU@icnarc.org 

Phone: 020 7269 9277

Trial Protocol
Statistical Analysis Plan
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