Neuroanaesthesia & neurocritical care
Normobaric hyperoxia combined with endovascular treatment for acute ischaemic stroke in China (OPENS-2 trial): a multicentre, randomised, single-blind, sham-controlled trial
Authors' conclusion
In patients with acute ischaemic stroke caused by large-vessel occlusion in the anterior circulation who were candidates for endovascular treatment, normobaric hyperoxia yielded superior functional outcomes at 90 days compared with the sham normobaric hyperoxia, without raising safety concerns.
Study context
- Population
- Patients aged 18–80 years within 6 h of acute ischaemic stroke due to anterior-circulation large-vessel occlusion, candidates for endovascular treatment, 26 comprehensive stroke centres in Chinarandomised
- Participants
- 282 patients
- Comparison
- Normobaric hyperoxia vs Sham normobaric hyperoxia
- Normobaric hyperoxian = 140
- Sham normobaric hyperoxian = 142reference
- Primary endpoint
- Ordinal modified Rankin Scale (mRS) scores (ITT population)
- Follow-up
- Up to 90 days
Methodological detailsmulticentre, single-blind, sham-controlled
- Multicentre
- Single-blind
- Sham-controlled
Primary result
mRS score
Adjusted common OR
1.65
95% CI 1.09–2.50
P = 0.018
By group
Normobaric hyperoxia
2
median · IQR 1–4
Sham normobaric hyperoxia
3
median · IQR 1–4
Normobaric hyperoxia vs Sham normobaric hyperoxia
adjusted common OR 1.65 (95% CI 1.09–2.50); P = 0.018
As reported in the abstract
Further findings
| Outcome | Normobaric hyperoxia | Sham normobaric hyperoxia | Adjusted risk difference (95% CI) | |
|---|---|---|---|---|
| Death · up to 90 days | 10% | 12% | −0.02 (−0.09 to 0.06) | |
| −0.1−0.0500.050.1Difference (linear scale) |
Safety
| Outcome | Normobaric hyperoxia | Sham normobaric hyperoxia | Adjusted risk difference (95% CI) | |
|---|---|---|---|---|
| Serious adverse events · up to 90 days | 20% | 23% | −0.03 (−0.12 to 0.07) | |
| −0.15−0.1−0.0500.050.1Difference (linear scale) |
Original publication
Normobaric hyperoxia combined with endovascular treatment for acute ischaemic stroke in China (OPENS-2 trial): a multicentre, randomised, single-blind, sham-controlled trial. Lancet. Published 8 February 2025. doi:10.
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