6/28/23, 11:32 PM ICU-ROX Pathway Feedback Search Clinical Topics Home Studies ICU ROX ICU ROX Trial question What is the effect of conservative oxygen therapy in adult patients undergoing mechanical ventilation in the ICU? Study design Multi-center Open label RCT Population Characteristics of study participants 37.0% female N = 965 63.0% male 965 patients (357 female, 608 male) Inclusion criteria: adult patients who were anticipated to require mechanical ventilation beyond the day after recruitment in the ICU Key exclusion criteria: life expectancy < 90 days due to a chronic or underlying medical condition; admitted following a drug overdose; long-term dependence on invasive ventilation prior to this acute illness; pregnancy Interventions N=484 conservative oxygen therapy (No supplemental oxygen use when the SpO2 is > 97%, and the FiO2 was decreased to 0.21 when the SpO2 was above the acceptable lower limit of 91%) N=481 usual oxygen therapy (no specific measures limiting supplemental oxygen use and the FiO2) Primary outcome Number of ventilator-free days at day 28 22.1 days 22.1 21.3 16.6 days 11.1 days 5 5 d https://web.pathway.md/studies/reclNFf9ZEq68sUdj 1/2 6/28/23, 11:32 PM 5.5 days ICU-ROX Pathway No significant difference 0.0 days Conservative oxygen therapy Usual oxygen therapy No significant difference in the number of ventilator-free days at day 28 (21.3 days vs. 22.1 days; AD -0.3 days, 95% CI -2.1 to 1.6) Secondary outcomes No significant difference in death at day 180 (35.7% vs. 34.5%; OR 1.05, 95% CI 0.81 to 1.37) No significant difference in time from randomization to ICU discharge (115 hours vs. 124 hours; AD -8.4 hours, 95% CI -27.7 to 10.9) No significant difference in the percentage of patients who received RRT in ICU (19.4% vs. 22.5%; OR 0.83, 95% CI 0.61 to 1.14) Safety outcomes No significant difference in adverse events. Significant differences in severe problems with walking around (2.8% vs. 8.7%), severe problems with washing or dressing (0.8% vs. 4%). Conclusion In adult patients who were anticipated to require mechanical ventilation beyond the day after recruitment in the ICU, conservative oxygen therapy was not superior to usual oxygen therapy with respect to number of ventilator-free days at day 28. Reference ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group, Diane Mackle, Rinaldo Bellomo et al. Conservative Oxygen Therapy during Mechanical Ventilation in the ICU. N Engl J Med. 2020 Mar 12;382(11):989-998. Open reference URL https://web.pathway.md/studies/reclNFf9ZEq68sUdj 2/2