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Progressing stroke is associated poor functional outcome and neurological deficit.
Currently, no treatment for progressing stroke is recommended on the guideline.
Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia.
CO2 dilate cerebral arteriole and concentration of CO2 is correlated with cerebral blood flow.
Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressing stroke.
Induced hypertension is alternative treatment of progressing stroke. Increasing blood pressure also induce cerebral blood flow. Phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart. Several studies reported that the effectiveness of phenylephrine on progressing stroke.
Therefore, this study will compare the effectiveness of carbogen + phenyleprhine versus phenlyephrine in progressing stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbogen + phenylephrine group | Experimental |
| |
| Phenylephrine group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbogen with or without phenyleprhine | Drug | Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes. All patients will recevive phenyleprhine to increase blood pressure. Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg. |
| Measure | Description | Time Frame |
|---|---|---|
| percent improvement of NIHSS score in each group | (baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS scoreĆ100 | 24 hours |
| difference of NIHSS score in each group | baseline NIHSS score-post-treatment NIHSS score | 24 hours |
| percent improvement of MRC score in each group | (baseline MRC score-post-treatment MRC score)/baseline MRC scoreĆ100 | within 24 hours |
| difference of MRC score in each group | baseline MRC score-post-treatment MRC score | difference of MRC score in each group |
| Saftety outcome: Side effect | Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc) | within 7 days |
| Saftety outcome: discontinuing patients | Number of discontinuing patients due to side effects | within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparision between groups by percent improvement of NIHSS score | (baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS scoreĆ100 | 24 hours |
| Comparision between groups by differnece of NIHSS score |
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Inclusion Criteria:
Exclusion Criteria:
Myocardial infarction or unstable angina within the past 3 months. Cardiac ejection fraction < 25%. Ventricular arrhythmia. Systolic blood pressure > 200 mmHg. Serum creatinine > 2 mg/dL. Pregnancy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D059409 | Stroke, Lacunar |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C011700 | carbogen |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Three months after discharge, the independence assessment will be perfomred by the researcher who don't know the patietns group.
|
| phenylephrine | Drug | All patients will recevive phenyleprhine to increase blood pressure. Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg. |
|
baseline NIHSS score-post-treatment NIHSS score
| 24 hours |
| Comparision between groups by percent improvement in MRC score | (baseline MRC score-post-treatment MRC score)/baseline MRC scoreĆ100 | within 24 hours |
| Comparision between groups by difference of MRC score | baseline MRC score-post-treatment MRC score | within 24 hours |
| Functional independencec | modifed Rankin score 0 to 2 | 3 months after onset |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D059345 | Cerebral Small Vessel Diseases |
| D000083244 | Thrombotic Stroke |
| D020520 | Brain Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000588 |
| Amines |