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This was a randomized, single-center trial. On the basis of standard-of-care, patients in the treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit. Patients in the control group received standard-of-care (consisting of oxygen therapy) alone. This study intends to apply Hydrogen/Oxygen Generator in clinical patients with aneurysmal subarachnoid hemorrhage (aSAH), exploring the role of hydrogen-oxygen mixed gas inhalation therapy in early brain injury, and the prevention of cerebral vasospasm and delayed cerebral ischemia, finally providing a scientific basis for hydrogen treatment of aSAH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | H2-O2 (66% hydrogen; 33% oxygen) inhalation. Patients in the treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit. |
|
| No intervention | No Intervention | Usual care refers to the standard-of-care (including oxygen therapy) recommended by guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen Oxygen Generator with Nebulizer | Device | Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit. |
| Measure | Description | Time Frame |
|---|---|---|
| In- hospital Cerebral Vasospasm | The proportion of patients with cerebral vasospasm at day 14 | From baseline to 14 days |
| In- hospital Delayed Cerebral Ischemia | The proportion of patients with delayed cerebral ischemia at day 14 | From baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale score | modified Rankin Scale score at 90 days after discharge | 90 days after discharge |
| Montreal Cognitive Assessment score | Montreal Cognitive Assessment score at 90 days after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Runting Li | Contact | +8615753166690 | tt18080lrt@163.com | |
| Fa Lin | Contact | +8613681107240 | 13681107240@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38863026 | Derived | Lin F, Li R, Chen Y, Yang J, Wang K, Jia Y, Han H, Hao Q, Shi G, Wang S, Zhao Y, Chen X. Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients with Aneurysmal Subarachnoid Hemorrhage (HOMA): study protocol for a randomized controlled trial. Trials. 2024 Jun 11;25(1):377. doi: 10.1186/s13063-024-08231-5. |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
| 90 days after discharge |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |