Intensive Care Unit Randomised Trial Comparing Two Approaches to OXygen Therapy.

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Status: Open to recruitment

The current version of the UK-ROX Trial Protocol can be downloaded here.
The current version of the UK-ROX Statistical Analysis Plan can be downloaded here.

What is this study about?

Each year, around 184,000 patients are admitted to NHS intensive care units (ICUs) and over 30% require help with their breathing using a ventilator (breathing machine). Giving oxygen through the ventilator is an essential part of this treatment. However, we do not know how much oxygen should be given to patients to optimise their recovery. Both too much, and too little, oxygen may cause harm. The concentration of oxygen given through the ventilator is adjusted according to how much oxygen can be detected in a patient’s blood, known as oxygen saturation. Some studies have shown that in unwell hospitalised patients, having a lower, rather than higher, oxygen saturation may be beneficial.

We are conducting a large-scale, clinical trial to find out whether using a lower oxygen target (conservative oxygen therapy) to guide oxygen treatment might lead to better outcomes for patients when compared with the approach currently used in the NHS (usual oxygen therapy) when treating ICU patients on an ventilator. The study will include 16,500 patients from around 100 UK ICUs. Patients will be randomly assigned to either the conservative or usual oxygen therapy group. We will follow all patients up to 90 days later by ‘linking’ study data with routinely collected national records. We will find out if conservative oxygen therapy was more effective than usual oxygen therapy by comparing the number of patients alive in each group at 90 days.

Patient recruitment started in May 2021 and is due to end in 2023. Results will have a large and immediate impact on ICU clinical practice and on patient outcomes throughout the NHS.

Who is leading this study?

Professor Daniel Martin OBE, University of Plymouth
Mr Paul Mouncey, ICNARC


National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (project number: NIHR130508).

Trial registration(s)

ISRCTN Registry: ISRCTN13384956
NIHR Central Portfolio Management System: 46926

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