Efficacy and safety of normobaric hyperoxia for acute ischemic stroke: a systematic review and meta-analysis of randomized controlled trials
Abstract
Summary Background The neuroprotective effects of normobaric hyperoxia (NBHO) for treating acute ischemic stroke (AIS) remain unclear. This systematic review and meta-analysis evaluated the safety and functional outcomes of NBHO in AIS patients. Methods We searched major databases until November 13, 2025, for randomized controlled trials (RCTs) comparing NBHO (≥2 h within 24 h of onset) with room air or low-flow oxygen in adult patients with AIS. Two reviewers independently screened studies, with disagreements resolved by a third reviewer. The primary outcome was functional independence (modified Rankin Scale [mRS] scores 0–2) at three months. Secondary outcomes included reduced disability (ordinal shift across mRS grades 0–6), early neurological recovery (changes in National Institutes of Health Stroke Scale [NIHSS] within 7 days), and infarct volume changes. Safety outcomes included 90-day mortality, symptomatic intracranial hemorrhage (sICH), and pneumonia. Outcomes eligible for meta-analysis were analyzed using a random-effects model (Paule-Mandel heterogeneity estimation) with Hartung-Knapp-Sidik-Jonkman (HKSJ) adjustment for the primary analysis and without HKSJ adjustment for secondary analysis. Registration: PROSPERO (CRD42024584308). Findings Eight RCTs involving 804 participants were included. Six studies (n = 746) showed that NBHO improved functional independence (RR 1.28, HKSJ 95% CI 1.07–1.51; P = 0.015), reduced disability (cOR 1.72, HKSJ 95% CI 1.35–2.20; P =…
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Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 804 participants or records.
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