Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial.
OBJECTIVE:To investigate the safety and efficacy of normobaric hyperoxia (NBO) combined with endovascular treatment (EVT) in acute ischemic stroke (AIS) patients. 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 alone group or the NBO+EVT group. The NBO+EVT group were given 100% oxygen via a face mask initiated before vascular recanalization (10L/min for 4h) while the EVT group were 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 1:1 (EVT group, n=43; NBO+EVT group, n=43). The median infarction volume of the NBO+EVT group at 24-48h 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 NBO+EVT group as compared with 3 for EVT group [adjusted value 1.8, 95% CI 1.3-4.2; p = 0.038]. Compared with the EVT group, the NBO+ET 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 is not statistically significant. CONCLUSION:NBO in combination with endovascular treatment appears 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 compared with endovascular treatment alone in AIS patients. These observations need to be further confirmed by a large multicenter, randomized clinical trial. CLASSIFICATION OF EVIDENCE:This pilot study provides Class I evidence that normobaric hyperoxia combined with standard endovascular treatment decreases infarction volume in patients with acute anterior circulation stroke. CLINICALTRIALS:gov identifier NCT03620370.