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Background <p>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.</p> Methods <p>In this randomized, controlled, two-arm (1:1 ratio), open-label clinical trial, participants were randomly assigned to either the NBO group (100% O<sub>2</sub> at 8 L/min for 1&#xa0;h per session, four times daily, for 7&#xa0;days) or the control group (100% O<sub>2</sub> at 2 L/min continuously for 24&#xa0;h daily for 7&#xa0;days). The primary outcome was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0–3 at 90&#xa0;days. The results are presented as the risk ratio (RR) with 95% confidence intervals (95% CI). <i>P</i> &lt; .05 indicated statistical significance.</p> Results <p>A total of 96 patients were enrolled (NBO, <i>n</i> = 48; control, <i>n</i> = 48). The proportion of patients who achieved an mRS score of 0–3 at 90&#xa0;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 <i>P</i> = .01; adjusted RR, 1.39; 95% CI, 1.06 to 1.82; adjusted <i>P</i> = .02). Additionally, the 90-day Barthel Index scores on days 7 and 14 were significantly higher in the NBO group (all <i>P</i> &lt; .05). Imaging assessments revealed that both absolute and relative perihematomal edema at 7 and 14&#xa0;days were reduced in the NBO group, and perfusion in the region surrounding the hematoma was improved at 7&#xa0;days compared to that in the control group (all <i>P</i> &lt; .05). No significant differences in oxygen-related complications were observed between the two groups (all <i>P</i> &gt; .05).</p> Conclusions <p>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.</p> Trial registration <p>NCT04144868.</p>

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Normobaric hyperoxia for intracerebral hemorrhage: a randomized clinical trial

  • 期刊论文

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  • 发表日期：

    2025年12月7日

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  • Zhiying Chen,
  • Jiayue Ding,
  • Bing Bao,
  • Moxin Wu,
  • Xianming Cao,
  • Weili Li,
  • Xiangbin Wu,
  • Zhongbin Xia,
  • Yuanyuan Xiang,
  • Liang Chen,
  • Hao Liu,
  • Xunming Ji,
  • Xiaoping Yin,
  • Ran Meng

摘要

Background

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.

Methods

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.

Results

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).

Conclusions

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.

Trial registration

NCT04144868.