NCT03620370已完成不适用
The Safety and Efficacy of Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke：A Randomized, Controlled Pilot Study
Capital Medical University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年8月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Cerebral infarct volume
研究概览
简要总结
NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age≥18 and ≤ 80;
- •Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1-segment of the MCA;
- •Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
- •Patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra;
- •NIHSS score≥6 分
- •Alberta Stroke Program Early CT score (ASPECTS) of 7-10 on non-contrast CT;
- •Informed consent obtained;
排除标准
- •Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization;
- •Seizures at stroke onset;
- •Intracranial hemorrhage;
- •Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits;
- •Symptoms rapidly improving;
- •Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
- •Platelet count of less than 100,000 per cubic millimeter;
- •CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere);
- •severe hepatic or renal dysfunction;
- •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;
- •inability to obtain informed consent;
- •Life expectancy<90 days;
- •Pregnant or breast-feeding women;
- •Unwilling to be followed up or poor compliance for treatment;
- •Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
- •Evidence of intracranial tumor;
- •Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol);
研究组 & 干预措施
NBO group
Experimental
Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start in the pre-hospital or emergency room as soon as possible (within 1 hours) after diagnosis of ischemic stroke and last for 4 hours. All participant will receive mechanical thrombectomy and a standard clinical therapy.
干预措施: Normobaric oxygen therapy (Drug)
结局指标
主要结局
Cerebral infarct volume
时间窗: 24-48h after randomization
Infarct volume is evaluated mainly through brain MRI(DWI)
次要结局
- Revascularization on 24-hour follow-up imaging(24 (12 to 36) hours;)
- Symptomatic Intracerebral Hemorrhage(24 (12 to 36) hours)
- Scores assessed by National Institutes of Health Stroke Scale(NIHSS)(2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ])
- modified Rankin Scale score (mRS)(30 ± 5 days, 90 ± 10 days after randomization)
- The good prognosis at 90 days assessed by modified Rankin scale (mRS).(90 ± 10 days after randomization)
- levels of blood biomarkers(baseline; 24 ± 6 hours, 7 ± 2 days)
- any intracranial hemorrhage on 24-hour follow-up imaging(24 (12 to 36) hours)
- Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours(from baseline to 24 ± 6 hours)
- 24-hour neurologic deterioration;(24 ± 6 hours;)
- Improvement of neurologic function after 24h(24 ± 6 hours;)
- Barthel Index (BI)(30 ± 5 days, 90 ± 10 days after randomization)
- Mortality and Stroke recurrence(90 ± 10 days after randomization)
- Survival rates(7 ± 2 days, 90 ± 10 days after randomization)
- TICI (Thrombolysis in Cerebral Infarction perfusion scale grade)(Time Frame: 4 hours ± 15 minutes)
- The infarct volume on 24-hour follow-up imaging(24 (12 to 36) hours;)
- mRS4-6(90 ± 10 days after randomization)
研究者
Ji Xunming,MD,PhD
professor
Capital Medical University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Treatment Duration on Normobaric Hyperoxia in Acute Ischemic StrokeStroke, AcuteNeuroprotectionEndovascular TreatmentNCT05404373Capital Medical University100
招募中
不适用
Normobaric Hyperoxia Stabilizing Ischemic PenumbraAcute Ischemic StrokeNCT05781880Ji Xunming,MD,PhD78
招募中
3 期
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L)Acute Ischemic StrokeNCT05965193Ji Xunming,MD,PhD1,230
招募中
3 期
Normobaric Oxygen in AIS Transferred for EVTIschemic StrokeNCT06666764Capital Medical University1,500
Unknown
不适用
Protective Effects of Normobaric Hyperoxia on Blood Brain Barrier in Patients With Acute Ischemic StrokeStroke, AcuteNCT02974283Capital Medical University40