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Trial question
What is the effect of low SpO2-directed oxygen therapy in critically ill patients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 1706
1706 patients (619 female, 1087 male).
Inclusion criteria: adult patients admitted to the ICU with an expected length of stay ≥ 72 hours.
Key exclusion criteria: pregnancy; acute exacerbation of COPD; severe ARDS; acute MI; paraquat poisoning; receipt of ECMO; withholding or withdrawal of life-sustaining treatment; failure to screen within 48 hours since admission to ICU; no informed consent.
Interventions
N=857 low SpO₂-directed oxygen therapy (target arterial oxyhemoglobin saturation 90-95%).
N=849 high SpO₂-directed oxygen therapy (target arterial oxyhemoglobin saturation ≥ 96%).
Primary outcome
Death at day 28
20.1%
22.7%
22.7 %
17.0 %
11.3 %
5.7 %
0.0 %
Low SpO2-directed oxygen therapy
High SpO2-directed oxygen therapy
No significant difference ↔
No significant difference in death at day 28 (20.1% vs. 22.7%; RR 0.88, 95% CI 0.74 to 1.06).
Secondary outcomes
No significant difference in ventilator-free time in 14 days (59 hours vs. 63 hours; AD -4 hours, 95% CI -26.46 to 18.46).
Borderline significant increase in RRT-free time in 14 days (120 hours vs. 120 hours).
No significant difference in mechanical ventilation during the study (68.1% vs. 69.4%; RR 0.98, 95% CI -2.39 to 4.35).
Conclusion
In adult patients admitted to the ICU with an expected length of stay ≥ 72 hours, low SpO₂-directed oxygen therapy was not superior to high SpO₂-directed oxygen therapy with respect to death at day 28.
Reference
Xiaobo Yang, Xuehui Gao, Xiang Zheng et al. Low versus high peripheral oxygen saturation directed oxygen therapy in critically ill patients: a multicenter randomized controlled trial. MedComm (2020). 2025 Feb 17;6(3):e70098.
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