Hypoxia Clinical Trial
Official title:
A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
A feasibility study to determine if it is possible to perform a safe, adequately powered, and affordable multi-centre study in critically ill children comparing current practice of liberal targets for systemic oxygen levels with more conservative targets.
Around 19,000 critically ill children are admitted to paediatric intensive care units (PICU)
each year in the UK. A large number of these children need breathing support, and this is
usually provided through an invasive machine called a 'ventilator'. Clinicians make decisions
for treatment based on how much oxygen their patient has in their blood (this is called
oxygen saturation or oxygenation) and currently the amount of oxygen critically ill children
need is not fully understood. This means that some clinicians use a lower oxygen saturation
target, and others, a higher target. This may be problematic as research in neonates (babies)
and adults has shown that oxygen saturation levels can influence a patient's chance of
survival, how long they stay in hospital and healthcare costs.
Response to oxygen is different in babies, children and adults. This means that the results
from the neonatal and adult research are unlikely to be valid or applicable in children due
to age-related differences. Urgent high quality clinical evidence is therefore needed to
inform on the best targets of oxygenation during critical illness in children.
As large clinical trials are expensive to conduct, it is important to demonstrate that a
large-scale trial can be done and that the different components of a trial can all work
together. Therefore, the Oxy-PICU study 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 a restrictive oxygen saturation target (88-92%) with
a more liberal oxygen saturation target (>94%). Oxy-PICU will also collect blood and urine
samples to allow for in depth study of the biology of the different oxygenation targets.
The pilot trial will take place at three PICUs (two in London and one in Southampton) and
aims to include between 115-125 eligible children over six months. Given the emergency nature
of these children and the need to provide immediate care, informed consent will be sought
after the children are entered into the study (this is known as deferred consent).
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