TRAUMOX2
Trial question
What is the role of early restrictive oxygen strategy in patients with trauma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 1508
1508 patients (413 female, 1095 male).
Inclusion criteria: adult patients with blunt or penetrating trauma.
Key exclusion criteria: suspicion of CO intoxication; cardiac arrest; no or minor injuries after secondary survey in the trauma resuscitation room.
Interventions
N=750 restrictive oxygen strategy (SaO2 target of 94% over 8 hours).
N=758 liberal oxygen strategy (12-15 L of oxygen per minute or FiO2 of 0.6-1.0 over 8 hours).
Primary outcome
Rate of death and/or major respiratory complications within 30 days
16.1%
16.7%
16.7 %
12.5 %
8.3 %
4.2 %
0.0 %
Restrictive oxygen
strategy
Liberal oxygen
strategy
No significant
difference ↔
No significant difference in the rate of death and/or major respiratory complications within 30 days (16.1% vs. 16.7%; OR 1.01, 95% CI 0.75 to 1.37).
Secondary outcomes
No significant difference in death at day 30 (8.6% vs. 7.3%; OR 1.28, 95% CI 0.85 to 1.92).
No significant difference in major respiratory complications at day 30 (8.9% vs. 10.8%; OR 0.84, 95% CI 0.59 to 1.19).
Significant increase in hypoxemic episodes (6% vs. 3.8%; OR 1.67, 95% CI 1.02 to 2.7).
Safety outcomes
No significant difference in adverse and serious adverse events.
Significant difference in atelectasis (27.6% vs. 34.7%).
Conclusion
In adult patients with blunt or penetrating trauma, restrictive oxygen strategy was not superior to liberal oxygen strategy with respect to the rate of death and/or major respiratory complications within 30 days.
Reference
Tobias Arleth, Josefine Baekgaard, Volkert Siersma et al. Early Restrictive vs Liberal Oxygen for Trauma Patients: The TRAUMOX2 Randomized Clinical Trial. JAMA. 2025 Feb 11;333(6):479-489.
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