Targeted Normoxemia and Supplemental Oxygen–Free Days in Critically Injured Adults: A Stepped-Wedge Cluster Randomized Clinical Trial
Primary result · SOFDsResult — go to the resultAdjusted mean difference 0.32 days 95% CI −0.37 to 1.00Authors' conclusion
This randomized clinical trial showed that targeting normoxemia did not increase the number of SOFDs but safely reduced supplemental oxygen use among critically ill trauma patients.
Study context
- Population
- Adult trauma patients admitted to an intensive care unit (ICU) at 8 level I trauma centers across the US
- Participants
- 12,487 patients · 8 trauma centers
- Comparison
- Targeted normoxemia vs usual care
- Primary endpoint
- Supplemental oxygen-free days (SOFDs): days alive and not receiving supplemental oxygen
- Follow-up
- Through day 28
Methodological detailsmulticentre, stepped-wedge, intention-to-treat, Enrolment July 15, 2020, to November 14, 2022, Centers randomised at 3-month intervals to cross over from usual care to targeted normoxemia
- Multicentre
- Stepped-wedge
- Intention-to-treat
- Enrolment July 15, 2020, to November 14, 2022
- Centers randomised at 3-month intervals to cross over from usual care to targeted normoxemia
Primary result
SOFDs
Adjusted mean difference
0.32 days
95% CI −0.37 to 1.00
P = 0.30
By group
Targeted normoxemia vs Usual care
adjusted mean difference 0.32 days (95% CI −0.37 to 1.00); P = 0.30
As reported in the abstract
Further findings
Proportion of ICU time in normoxemia
Hyperoxemia (SpO2 >96%)
Mean, days
| Outcome | Targeted normoxemia | Usual care | Adjusted mean difference (days) (95% CI) | |
|---|---|---|---|---|
| SOFDs, patients not receiving mechanical ventilation at ICU admission (subgroup) | 22.6 (SD 8.30) | 20.6 (SD 8.86) | 0.75 (0.00–1.50) | |
| −1012Difference, days (linear scale) |
| Outcome | Targeted normoxemia | Usual care | aHR (95% CI) | |
|---|---|---|---|---|
| Time for weaning to room airMean, days | 1.6 (SD 3.2) | 2.7 (SD 4.0) | 1.23 (1.13–1.33) | |
| In-hospital mortality · to day 90 | 9.9% | 10.7% | 1.05 (0.83–1.33) | |
| 0.512Adjusted hazard ratio (log scale) |
Safety
Hypoxemia (SpO2 <88%) during ICU admission
Events
| Outcome | Targeted normoxemia | Usual care |
|---|---|---|
| Adverse events | 0 | 0 |
Hypoxemia (SpO2 <88%) during ICU admission
- Similar between groups
Original publication
Targeted Normoxemia and Supplemental Oxygen–Free Days in Critically Injured Adults: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. Published 3 March 2025. doi:10.
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