What is this study about?

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.

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UK-ROX is 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 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.

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Eligibility

•Inclusion criteria

oAged ≥18 years

oReceiving invasive mechanical ventilation following an unplanned ICU admission OR invasive mechanical ventilation started in the ICU

oFIO2 >0.21 at time of randomisation

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•Exclusion criteria

oPreviously randomised to UK-ROX in last 90 days

oCurrently receiving ECMO

oThe treating clinician considers that one study treatment arm
is either indicated or contraindicated

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•Patients must be randomised within 12 hours of starting invasive mechanical ventilation in ICU

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Intervention Period

•Begins immediately following randomisation

•The interventions remain the same once a patient is extubated, regardless of the modality by which they receive oxygen therapy

•The interventions should be continued until ICU discharge or 90 days after randomisation, whichever is sooner

oIf readmitted to ICU within the 90 days, the intervention should be recommenced

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Intervention Group (Conservative O2 therapy)

•The lowest concentration of oxygen possible should be administered to maintain the patient’s SpO2 at 90(±2)%

•For patients receiving oxygen, SpO2 should not rise above 92% (monitor alarm set to 93%)

•SpO2 should not fall lower than 88%

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Usual Therapy Group (Standard of Care)

•Defined by local practice, determined by treating clinician

•Chosen SpO2 targets should be documented daily

•A lower limit alarm can be set at the discretion of the treating clinician

•An upper SpO2 alarm must not be used

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Outcomes

•Primary

oAll-cause mortality at 90 days (clinical)

oIncremental costs, quality-adjusted life years and net monetary benefit at 90 days (economic)

•Secondary

oICU and acute hospital mortality

o60-day and 1-year mortality

oDuration of ICU and acute hospital stay

oHealth-related Quality of Life at 90 days

oResource use and costs at 90 days

oEstimated lifetime incremental cost-effectiveness

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Patient recruitment will start in spring 2021 and end in 2023. Results will have a large and immediate impact on ICU clinical practice and on patient outcomes throughout the NHS.

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