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The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBO+EVT group | Experimental | Normobaric hyperoxia Combined with Endovascular therapy group were given 100% oxygen via a face mask initiated before vascular recanalization (10L/min for 4h) . In addition, the patient will be given endovascular therapy surgery. |
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| EVT group | No Intervention | The Endovascular therapy group were given room air. And the patient will also be given endovascular therapy surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normobaric oxygen therapy | Other | it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours.This therapy should begin in the emergency room as early as possible when patients meet the inclusion criteria and are randomized to the experimental group |
| Measure | Description | Time Frame |
|---|---|---|
| Early neurologic improvement (ENI) at 24 hours | ENI was defined as percent change NIHSS≥30%; Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score]; | 24 ± 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale(NIHSS) Score | the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits | 4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization |
| modified Rankin Scale score (mRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD | Xuanwu Hospital of Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital of Capital Medical University | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42403344 | Derived | Li W, Hu W, Wang S, Chen Z, Ding J, Ma Q, Liu KJ, Feng W, Liu S, Ji X. Adjunctive Normobaric Hyperoxia With Endovascular Thrombectomy for Acute Stroke at 6 to 24 Hours: A Phase IIb Randomized Trial. Stroke. 2026 Jul 6. doi: 10.1161/STROKEAHA.125.055019. Online ahead of print. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
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 ± 14 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) | 24 ± 12 hours after randomization |
| 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); | 90 ± 14 days after randomization |
| Revascularization on 24-hour follow-up imaging | secondary imaging efficacy endpoint;Successful recanalization was defined as mTICI 2b or 3 | 24 ± 12 hours hours after randomization |
| Early 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 ± 12 hours after randomization |
| 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 hours hours after randomization |
| Mortality | clinical safety endpoint; | 90 ± 14 days after randomization |
| Stroke recurrence | clinical safety endpoint; | 90 ± 14 days,180 ± 30 days after randomization |
| The 5-level EuroQol five dimensions questionnaire(EQ-5D-5L)score | secondary clinical efficacy endpoint, Quality of Life score; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | 90 ± 14 days after randomization |
| Delta NIHSS | Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score). | 24 ± 12 hours after randomization |
| Percent change NIHSS | Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score] | 24 ± 12 hours after randomization |
| Cerebral infarct volume | Infarct volume is evaluated mainly through brain MRI(DWI) or CT | 36 ± 12 hours after randomization |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |