Conservative Oxygen Therapy during Mechanical Ventilation in the ICU
ICU-ROX trial design and results
Design
Multicentre randomised controlled trial
Treatment
Conservative oxygen therapy
Control
Usual oxygen therapy
Population
1000 adults undergoing mechanical ventilation in intensive care
Follow-up
180 days
Primary endpoint
Ventilator-free days to day 28
Result
Median ventilator-free days 21.3 (IQR 0 to 26.3) with conservative oxygen versus 22.1 (0 to 26.2) with usual oxygen — absolute difference -0.3 days (95% CI -2.1 to 1.6, p=0.80). Mortality at 180 days was 35.7% with conservative oxygen and 34.5% with usual oxygen — unadjusted odds ratio 1.05 (95% CI 0.81 to 1.37).
Secondary endpoints
Mortality at 90 and 180 days, ICU and hospital length of stay
In adults undergoing mechanical ventilation in the ICU, the use of conservative oxygen therapy, as compared with usual oxygen therapy, did not significantly affect the number of ventilator-free days.
The trial authors, in the published abstract
How it has aged
The first of the three large neutral oxygen-target trials, later joined by PILOT and UK-ROX. Its limitation is that usual care in participating units was already fairly conservative, so the separation between arms was modest — a criticism UK-ROX largely answers with scale.
Publications
Conservative Oxygen Therapy during Mechanical Ventilation in the ICU
Mackle D, Bellomo R, Bailey M, et al. Conservative Oxygen Therapy during Mechanical Ventilation in the ICU. N Engl J Med 2020 Mar 12;382(11):989-998.
No difference in ventilator-free days
Separation between the two oxygen strategies was modest