Oxy-PICU RCT
Research type
Research Study
Full title
A Randomised Multiple Centre Trial of Conservative versus Liberal Oxygenation Targets in Critically Ill Children (Oxy-PICU)
IRAS ID
272768
Contact name
Mark Peters
Contact email
Sponsor organisation
Intensive Care National Audit and Research Centre
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Around 20,000 children are admitted to paediatric intensive care units (PICU) each year in the UK. Around 75% of children admitted to PICU will receive additional oxygen, often in combination with a ventilator. Doctors and nurses adjust oxygen treatment based on how much oxygen their patient has in their blood, known as oxygen saturations. Whilst we know very low oxygen saturations are harmful, current research shows that very high saturations may also be dangerous for very ill people.
Recent research in adults has shown that high oxygen saturations can lead to worse outcomes in emergencies like heart attacks and strokes. We don't know if this harm is an effect of the oxygen level itself or a side-effect of the treatments given to keep oxygen levels high. Because of the differences in child and adult bodies, the results of this research cannot be applied to children.
Our aim is to find out whether children in intensive care, who are receiving oxygen while needing help from a ventilator, should have their oxygen saturations kept at a lower level (88-92%, which is within recommended guidelines) or at the level currently used (95-100%). We are conducting a clinical trial of 2,000 children from 15 NHS PICUs. They will be randomly assigned to the higher or lower group which ensures that the two groups are as similar as possible. All other medical care will be decided by the doctors and nurses. We will follow-up all the children in the study after 90 days and one year to see how they are after leaving PICU.
If critically ill children on intensive care can be managed safely with slightly lower oxygen saturations, they might need less intensive treatment and may recover more quickly. This is why it is very important we answer this question in children.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0362
Date of REC Opinion
13 Dec 2019
REC opinion
Favourable Opinion