Early Hydrogen-Oxygen Gas Mixture Inhalation Therapy for Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 206
- 主要终点
- In- hospital Cerebral Vasospasm
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Signed informed consent
- •Must be admitted within 72 hours after aneurysm rupture
排除标准
- •physical disability caused by any reason before the onset of the disease
- •dementia or mental illness before the onset of the disease
- •more than 72 hours after aneurysm rupture admitted to hospital for treatment
- •do not cooperate with the treatment
结局指标
主要结局
In- hospital Cerebral Vasospasm
时间窗: From baseline to 14 days
The proportion of patients with cerebral vasospasm at day 14
In- hospital Delayed Cerebral Ischemia
时间窗: From baseline to 14 days
The proportion of patients with delayed cerebral ischemia at day 14
次要结局
- modified Rankin Scale score(90 days after discharge)
- Montreal Cognitive Assessment score(90 days after discharge)