Normobaric hyperoxia for intracerebral hemorrhage: a randomized clinical trial.

Abstract

Intracerebral hemorrhage (ICH) is a challenging and life-threatening stroke subtype. Normobaric hyperoxia (NBO) is a promising therapeutic strategy for ICH. Herein, we evaluated the safety and efficacy of NBO in patients with ICH. In this randomized, controlled, two-arm (1:1 ratio), open-label clinical trial, participants were randomly assigned to either the NBO group (100% O₂ at 8 L/min for 1 h per session, four times daily, for 7 days) or the control group (100% O₂ at 2 L/min continuously for 24 h daily for 7 days). The primary outcome was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-3 at 90 days. The results are presented as the risk ratio (RR) with 95% confidence intervals (95% CI). P < .05 indicated statistical significance. A total of 96 patients were enrolled (NBO, n = 48; control, n = 48). The proportion of patients who achieved an mRS score of 0-3 at 90 days was significantly higher in the NBO group than in the control group (81.3% vs. 56.3%; unadjusted RR, 1.44; 95% CI, 1.09-1.92; unadjusted P = .01; adjusted RR, 1.39; 95% CI, 1.06 to 1.82; adjusted P = .02). Additionally, the 90-day Barthel Index scores on days 7 and 14 were significantly higher in the NBO group (all P < .05). Imaging assessments revealed that both absolute and relative perihematomal edema at 7 and 14 days were reduced in the NBO group, and perfusion in the region surrounding the hematoma was improved at 7 days compared to that in the control group (all P < .05). No significant differences in oxygen-related complications were observed between the two groups (all P > .05). Early intermittent administration of NBO in patients with ICH may improve 90-day outcomes without increasing the risk of death or other oxygen-related complications. NCT04144868.