Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
Condition: Critical Care; Hypoxia; Pediatric ALL
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Conservative oxygenation target; Liberal oxygenation target
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants allocated to the conservative oxygenation target group will receive supplemental oxygen and ventilator settings at the discretion of the treating clinical team with the aim of peripheral oxygen saturations remaining 88-92% (inclusive).; Participants allocated to the liberal oxygenation target group will receive supplemental oxygen and ventilator settings at the discretion of the treating clinical team with the aim of peripheral oxygen saturations remaining >94%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment