UK-ROX
Research type
Research Study
Full title
Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care.
IRAS ID
288506
Contact name
Daniel Martin
Contact email
Sponsor organisation
Intensive Care National Audit & Research Centre (ICNARC)
ISRCTN Number
ISRCTN13384956
Duration of Study in the UK
3 years, 3 months, 30 days
Research summary
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 more be beneficial.
We therefore intend to conduct a large 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 NHS ICUs (usual oxygen therapy). The study will include 16,500 patients from 100 UK NHS ICUs. Patients will be randomly assigned to either the conservative oxygen therapy 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 will start early in 2021 and end in 2023. Results will have a large and immediate impact on ICU clinical practice and on patient outcomes throughout the NHS. Data from the 16,500 patients in this study will also contribute to a larger global study of 40,000 patients. The global study will answer similar questions about oxygen therapy in ICU patients but from an international perspective.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0423
Date of REC Opinion
8 Dec 2020
REC opinion
Favourable Opinion