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NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBO group | Experimental | Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start in the pre-hospital or emergency room as soon as possible (within 1 hours) after diagnosis of ischemic stroke and last for 4 hours. All participant will receive mechanical thrombectomy and a standard clinical therapy. |
|
| Control group | No Intervention | The participants receive mechanical thrombectomy therapy after diagnosed ischemic. All participants receive a standard clinical therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normobaric oxygen therapy | Drug | In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral infarct volume | Infarct volume is evaluated mainly through brain MRI(DWI) | 24-48h after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| levels of blood biomarkers | Biomarkers for evaluation of BBB damage and brain injury:NSE、S100B、occludin、 claudin-5、MMP-9 | baseline; 24 ± 6 hours, 7 ± 2 days |
| modified Rankin Scale score (mRS) | secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death) |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analysis of infarct volume | Stratify according to different risk factors：ASPECT; NIHSS; age;Ischemic penumbra volume; Site of occlusion; Time from stroke onset to randomization;Ischemic penumbra volume | 24-48h after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu hospital;Capital Medical University | Beijin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41065265 | Derived | Niu H, Ding J, Chen Z, Yuan S, Qi Z, Ji X, Li W. Normobaric Hyperoxia in Patients With Acute Stroke: Enhancing Neuroprotection Through Inhibition of Inflammation. J Am Heart Assoc. 2026 Mar 17;15(6):e041825. doi: 10.1161/JAHA.125.041825. Epub 2025 Oct 9. | |
| 35715198 | Derived | Li W, Qi Z, Ma Q, Ding J, Wu C, Song H, Yang Q, Duan J, Liu L, Kang H, Wu L, Ji K, Zhao W, Li C, Sun C, Li N, Fisher M, Ji X, Liu KJ. Normobaric Hyperoxia Combined With Endovascular Treatment for Patients With Acute Ischemic Stroke: A Randomized Controlled Clinical Trial. Neurology. 2022 Aug 23;99(8):e824-e834. doi: 10.1212/WNL.0000000000200775. Epub 2022 Jun 17. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 30 ± 5 days, 90 ± 10 days after randomization |
| The good prognosis at 90 days assessed by modified Rankin scale (mRS). | secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2; | 90 ± 10 days after randomization |
| Scores assessed by National Institutes of Health Stroke Scale(NIHSS) | secondary clinical efficacy endpoint; the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits | 2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ] |
| Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours | secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits) | from baseline to 24 ± 6 hours |
| Improvement of neurologic function after 24h | NIHSS score decreased by more than 4 points or NIHSS score was 0;secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits) | 24 ± 6 hours; |
| Barthel Index (BI) | secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis); | 30 ± 5 days, 90 ± 10 days after randomization |
| Revascularization on 24-hour follow-up imaging | secondary imaging efficacy endpoint; | 24 (12 to 36) hours; |
| 24-hour neurologic deterioration; | NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint; | 24 ± 6 hours; |
| any intracranial hemorrhage on 24-hour follow-up imaging | imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification | 24 (12 to 36) hours |
| Symptomatic Intracerebral Hemorrhage | imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification | 24 (12 to 36) hours |
| Mortality and Stroke recurrence | clinical safety endpoint; | 90 ± 10 days after randomization |
| Survival rates | secondary clinical efficacy endpoint; | 7 ± 2 days, 90 ± 10 days after randomization |
| TICI (Thrombolysis in Cerebral Infarction perfusion scale grade) | secondary imaging efficacy endpoint; | Time Frame: 4 hours ± 15 minutes |
| The infarct volume on 24-hour follow-up imaging | The infarct volume of cerebral infarct is evaluated by cranial CT; | 24 (12 to 36) hours; |
| mRS4-6 | secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death) | 90 ± 10 days after randomization |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |