Normobaric Hyperoxia Stabilizing Ischemic Penumbra

Study Overview
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Brief Summary
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To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.

Detailed Description
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All the enrolled patients were randomly assigned to NBO and control group. NBO group will be given 100% oxygen ( (10L/min for 4h) via a storage oxygen face mask and control group will be given oxygen using nasal oxygen(2L/min for 4h) .

Official Title
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Efficiency and Safety Evaluation of Normobaric Hyperoxia Stabilizing the Penumbra in Patients With Acute Ischemic Stroke

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Other: Oxygen 100%


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age≥18岁 The signs and symptoms are consistent with anterior circulation infarction, and baseline NIHSS score：6-20 Level of consciousness on admission：0-1 mRS score before stroke: 0-1 Patients who did not receive revascularization therapy The time from onset (finally normal) to randomization is less than 24h Patients who signed informed consent CTA or MRA confirmed internal carotid artery occlusion or M1/M2 segment occlusion of middle cerebral artery The low-perfusion area with Tmax>6s was larger than the core infarction, and the mismatch ratio was greater than or equal to 1.8. Exclusion Criteria: Evidence of rapid improvement in neurological function and NIHSS score <6, or spontaneous recanalization before randomization The disease affecting assessment of baseline NIHSS score (dementia, epilepsy, neuromuscular disease, or psychiatric disease) Symptoms suggesting subarachnoid hemorrhage (even if CT scan is normal) Combined with the history, cerebral embolism due to sepsis or infective endocarditis was suspected Active or chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, pleural effusion, acute respiratory distress syndrome, irregular breathing It is necessary to inhale (>3L/min) oxygen to maintain peripheral arterial oxygen saturation (SaO2>95%) Anemia or polycythemia vera or other conditions needing emergency oxygen patients Patients with upper gastrointestinal bleeding or nausea and vomiting can not complete inhalation oxygen using face mask Baseline blood glucose <2.78mmol/L or >22.2mmol/L Baseline platelet count <50×109/L Hereditary or acquired bleeding tendency, lack of coagulation factor, recent oral anticoagulant INR>3 or PPT more than 3 times Unstable vital signs (heart rate ≤50 beats/min or ≥120 beats/min, oxygen saturation ≤90%, R≥30 beats/min or ≤10 beats/min) Hypertension not controlled by medication: systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg Acute myocardial infarction suspected Pregnancy, Life expectancy <90 days Heart, liver and kidney failure Magnetic resonance contraindications Claustrophobia Allergic to contrast media Participating in other drug or device research

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 group<br>Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask. | Other: Oxygen 100%<br>* NBO therapy were given 100% oxygen via a face mask (10L/min for 4h)<br>* Other names: Normobaric hyperoxia;|
| Placebo Comparator: Control group<br>Control group will be given nasal oxygen (2L/min for 4h）. All other therapy measures are the same as experimental group. | Other: Oxygen 100%<br>* NBO therapy were given 100% oxygen via a face mask (10L/min for 4h)<br>* Other names: Normobaric hyperoxia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changing of penumbra volume from baseline | the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| penumbra volume at 4h following randomizing | the absolute penumbra volume comparison between NBO and control group | Day 0 | 
| volume of core infarction at 4h following randomizing | core infarction volume comparison between NBO and control group | Day 0 | 
| volume of hypoperfusion region hypoperfusion at 4h following randomizing | the volume of hypoperfusion region hypoperfusion comparison between NBO and control group | Day 0 | 
| National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing | the comparison of NIHSS score between NBO and control group; NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome. | Day 1 | 
| modified rankin scale (mRS) score at 90 days following randomizing | the mRS score comparison between NBO and control group; mRS score ranges from 0 to 5, and the higher score means a worse outcome. | Month 3 | 
| Barthel Index at 90 days following randomizing | the comparison of Barthel Index between NBO and control group | Month 3 | 
| EQ-5D index at 90 days following randomizing | the comparison of EQ-5D index between NBO and control group | Month 3 | 
| BBB injured biomarkers at baseline and 24h following randomizing | the levels of BBB injured biomarkers comparison between NBO and control group | Day 1 | 
| Cerebral oxygen concentration at baseline and 4h following randomizing | the levels of cerebral oxygen comparison between NBO and control group | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normobaric Hyperoxia, Acute ischemic stroke, penumbra