Randomised Pilot Trial of Oxygen Targets in PICU (Oxy-PICU) v1.0
Research type
Research Study
Full title
A Randomised Pilot Multiple Centre Trial of Conservative versus Liberal Oxygenation Targets in Critically Ill Children
IRAS ID
212228
Contact name
Mark J Peters
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
The Oxy-PICU study will test if children in paediatric intensive care units (PICUs) can benefit from doctors and nurses allowing blood oxygen levels to be lower (88-92% oxygen saturation) than the levels that are typically aimed for now (greater than or equal to 95% oxygen saturation).
This study is important because other research has shown that too much oxygen can damage body cells and also that PICU treatments to raise blood oxygen levels have some risks of side effects. So, if a child in PICU can manage safely with a lower blood oxygen level, we might expect that they would recover more quickly.
Results from adult patients and children with chest infections are very encouraging. They suggest that lower oxygen levels may be better. But results from very premature babies show the opposite. Response to oxygen is different in babies, children and adults, which means we cannot directly apply any of these results to critically ill children. Urgent high quality evidence is therefore needed to inform on the optimal blood oxygen levels in critically ill children.
Large clinical trials can be expensive and difficult to conduct. Therefore, OXY-PICU is a ‘pilot randomised clinical trial’ (a smaller version of the trial we would like to conduct) and will test the feasibility and safety of conducting a large scale trial comparing the two different oxygen level targets.
Oxy-PICU is funded by the Great Ormond Street Hospital Children’s Charity and will take place at two Paediatric Specialist Retrieval Services and three PICUs (two in London and one in Southampton) and aims to include approximately 120 eligible children over six months and followed up during their stay in PICU. Children are eligible if they:
• are referred to one of the three PICUs as an emergency;
• receive invasive mechanical ventilation; and
• are receiving extra oxygen for low oxygen levelsREC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0617
Date of REC Opinion
19 Dec 2016
REC opinion
Further Information Favourable Opinion