NCT05781880招募中不适用
Efficiency and Safety Evaluation of Normobaric Hyperoxia Stabilizing the Penumbra in Patients With Acute Ischemic Stroke
Ji Xunming,MD,PhD1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年3月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- changing of penumbra volume from baseline
研究概览
简要总结
To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.
详细描述
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) .
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 (Outcomes Assessor)
盲法说明
Outcomes indexes will be assessed by trained neurologists or neuroradiologists who are blinded to the research content or patient grouping.
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
- •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.
排除标准
- •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
结局指标
主要结局
changing of penumbra volume from baseline
时间窗: Day 0
the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group
次要结局
- modified rankin scale (mRS) score at 90 days following randomizing(Month 3)
- Barthel Index at 90 days following randomizing(Month 3)
- EQ-5D index at 90 days following randomizing(Month 3)
- National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing(Day 1)
- BBB injured biomarkers at baseline and 24h following randomizing(Day 1)
- volume of core infarction at 4h following randomizing(Day 0)
- penumbra volume at 4h following randomizing(Day 0)
- volume of hypoperfusion region hypoperfusion at 4h following randomizing(Day 0)
- Cerebral oxygen concentration at baseline and 4h following randomizing(Day 0)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University
研究点 (1)
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