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To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.
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) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBO group | Experimental | Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask. |
|
| Control group | Placebo Comparator | Control group will be given nasal oxygen (2L/min for 4h). All other therapy measures are the same as experimental group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen 100% | Other | NBO therapy were given 100% oxygen via a face mask (10L/min for 4h) |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifeng Qi, Ph.D | Contact | 010-83199236 | qizhifeng@xwh.ccmu.edu.cn | |
| Shuhua Yuan, Ph.D | Contact | 15538260193 | 750495168@qq.com |
| 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 | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Outcomes indexes will be assessed by trained neurologists or neuroradiologists who are blinded to the research content or patient grouping.
| 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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |