NCT05404373已完成不适用
The Efficacy and Safety of Normobaric Hyperoxia on Treatment Duration for Acute Ischemic Stroke Patients With Endovascular Treatment
Capital Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cerebral infarct volume
研究概览
简要总结
Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.
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)
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
- •Symptoms and signs were consistent with acute anterior circulation stroke,
- •NIHSS score≥6 分;Alberta Stroke Program Early CT score (ASPECTS)≥6;
- •Met the indications for endovascular therapy;
- •(Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke
- •The time from onset to randomization was within 24 hours;
- •Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments);
- •Patients and their families signed informed consent
排除标准
- •Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
- •Seizures at stroke onset;
- •Intracranial hemorrhage;
- •Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
- •Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal;
- •Platelet count of less than 100,000 per cubic millimeter;
- •Severe hepatic or renal dysfunction;
- •Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg)
- •Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
- •>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;
- •Medically unstable;
- •Life expectancy<90 days;
- •Patients who could not complete the 90-day follow-up;
- •Evidence of intracranial tumor;
- •Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
- •Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.
- •A history of severe allergies to contrast agents;
结局指标
主要结局
Cerebral infarct volume
时间窗: Within 72 hours after randomization
The infarct volume is evaluated by MRI or CT scan
次要结局
- Scores assessed by National Institutes of Health Stroke Scale(NIHSS)(24hours, 72hours, day7 after randomization)
- neurological function improvement rate(Time Frame: 24 ± 6 hours)
- Incidence of any intracranial hemorrhage(24± 12 hours hours after randomization)
- Vital signs:heart rate: (times/min)(0 hours, 2 hours, 4 hours after randomization;)
- all-cause death rate(90 ± 10 days after randomization)
- Incidence of oxygen-related adverse events(24 ± 6 hours,)
- blood biomarkers : occludin(ng/ml), MMP-9(ng/ml), S100B(ng/ml),NSE(ng/ml),GFAP(ng/ml),PGP9.5(ng/ml),etc(24 ± 6 hours, 72 ± 24 hours)
- Incidence of adverse events(90 ± 10 days after randomization)
- Incidence of surgery-related complications(24± 12 hours hours after randomization)
- Vital signs:blood pressure(mmHg)(0 hours, 2 hours, 4 hours after randomization;)
- Vital signs:oxygen saturation (%)(0 hours, 2 hours, 4 hours after randomization;)
- The proportion of good prognosis(90 ± 10 days after randomization)
- modified Rankin Scale score (mRS) score(30 ± 7 days, 90 ± 10 days after randomization;)
- Vascular recanalization rate(Time Frame: 4 hours ± 15 minutes)
- Incidence of Symptomatic Intracerebral Hemorrhage(24± 12 hours hours after randomization)
- stroke related death rate(90 ± 10 days after randomization;)
- Vital signs:respiration(times/min)(0 hours, 2 hours, 4 hours after randomization;)
- Incidence of neurologic deterioration;(24 ± 6 hours;)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University
研究点 (1)
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