Normobaric Hyperoxia Combined with Endovascular Treatment for Patients with Acute Ischemic Stroke: A Randomized Controlled Clinical Trial

Weili Li, Zhifeng Qi, Qingfeng Ma, Jiayue Ding, Chuanjie Wu, Haiqing Song, Qi Yang, Jiangang Duan, Lan Liu, Huining Kang, Longfei Wu, Kangxiang Ji, Wenbo Zhao, Chuanhui Li, Chenghe Sun, Na Li, Marc Fisher, Xunming Ji, Ke Jian Liu

Research output: Contribution to journalArticlepeer-review

11 Scopus citations


Background and Objectives To investigate the safety and efficacy of normobaric hyperoxia (NBO) combined with endovascular treatment (EVT) in patients with acute ischemic stroke (AIS). Methods In this single-center, proof-of-concept, assessor-blinded, randomized, controlled pilot study, patients with AIS in the acute anterior circulation with large vessel occlusion who had an indication for EVT were randomly assigned to the EVT group or the NBO + EVT group. The NBO + EVT group was given 100% oxygen through a face mask initiated before vascular recanalization (10L/min for 4 hours), while the EVT group was given room air. The primary endpoint was infarct volume measured by MRI within 24-48 hours after randomization. Results A total of 231 patients were screened, and 86 patients were randomized into a ratio of 1:1 (EVT group, n = 43; NBO + EVT group, n = 43). The median infarction volume of the NBO + EVT group at 24-48 hours after randomization was significantly smaller than that of the EVT group (median 20.1 vs 37.7 mL, p < 0.01). The median mRS score at 90 days was 2 for the NBO + EVT group when compared with 3 for the EVT group (adjusted value 1.8, 95% CI 1.3-4.2; p = 0.038). Compared with the EVT group, the NBO + EVT group had a lower incidence of symptomatic intracranial hemorrhagic (7% vs 12%), mortality (9% vs 16%), and adverse events (33% vs 42%); however, such a difference was not statistically significant. Discussion NBO in combination with EVT seems to be a safe and feasible treatment strategy that could significantly reduce infarct volume, improve short-term neurobehavioral test score, and enhance clinical outcomes at 90 days when compared with EVT alone in patients with AIS. These observations need to be further confirmed by a large, multicenter, randomized clinical trial. Clinical Trials RegistrationNCT03620370.Classification of Evidence This pilot study provides Class I evidence that NBO combined with standard EVT decreases infarction volume in patients with acute anterior circulation stroke.

Original languageEnglish (US)
Pages (from-to)E824-E834
Issue number8
StatePublished - Aug 23 2022

Bibliographical note

Funding Information:
This work was partially supported by grants from Beijing Natural Science Foundation (7222080), Talent Construction Fund of Beijing Institute of Brain Disorders (Xunming Ji:PXM2020_014226_000004), and China Postdoctoral Science Foundation (W. Li, 2021M692252).

Publisher Copyright:
© American Academy of Neurology.

PubMed: MeSH publication types

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't


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