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Abstract
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 Registration NCT03620370.
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.
GLOSSARY
- ADC=
- apparent diffusion coefficient;
- AIS=
- Acute ischemic stroke;
- ASITN/SIR=
- American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology;
- BBB=
- Blood-brain barrier;
- CTP=
- CT Perfusion;
- DWI=
- diffusion-weighted imaging;
- END=
- Early neurological deterioration;
- EVT=
- Endovascular therapy;
- ICH=
- Intracranial Hemorrhage;
- IQR=
- interquartile range;
- ITT=
- intention to treat;
- mRS=
- modified Rankin scale;
- mTICI=
- Modified Thrombolysis in Cerebral Infarction;
- NBO=
- Normobaric hyperoxia;
- NIHSS=
- NIH Stroke scale;
- pO2=
- pressure of oxygen;
- sICH=
- Symptomatic Intracranial Hemorrhage
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
↵* These authors contributed equally to this work.
Submitted and externally peer reviewed. The handling editor was José Merino, MD, MPhil, FAAN.
Class of Evidence NPub.org/coe
- Received October 31, 2021.
- Accepted in final form April 8, 2022.
- © 2022 American Academy of Neurology
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- Author Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
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- Author Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
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- Reader Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
- Reader Response: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial
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