Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients Within 6-24 Hours of Symptom Onset

Conditions
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Stroke, Endovascular Treatment, Neuroprotection

Intervention / Treatment
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* Other: Normobaric oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age≥18; Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1/M2-segment of the MCA; Stroke symptom onset has been more than 6 hours but not more than 24 hours,and imaging confirmed the existenceof ischemic penumbra; NIHSS score≥6; Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non- contrast CT; (Level of consciousness) NIHSS score of 0 or 1 mRS score was 0-1 before stroke; Informed consent obtained; Exclusion Criteria: Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization; Seizures at stroke onset; Intracranial hemorrhage; Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits; Symptoms rapidly improving; Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal; Platelet count of less than 100,000 per cubic millimeter; CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere); severe hepatic or renal dysfunction; active and chronic obstructive pulmonary disease or acute respiratory distress syndrome; >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)#95% as per current stroke management guidelines; medically unstable; inability to obtain informed consent; Life expectancy<90 days; Pregnant or breast-feeding women; Unwilling to be followed up or poor compliance for treatment; Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial; Evidence of intracranial tumor; Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol); Patients with upper gastrointestinal bleeding or nausea and vomiting who cannot use oxygen masks; Other circumstances requiring emergency oxygen inhalation;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBO+EVT group<br>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. | Other: Normobaric oxygen therapy<br>* 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<br>|
| No Intervention: EVT group<br>The Endovascular therapy group were given room air. And the patient will also be given endovascular therapy surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |