Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the incidence of early neurological improvement (ENI)
研究概览
简要总结
The goal of this clinical trial is to compare the effects of different concentrations of normobaric oxygen on early neurological improvement in acute ischemic stroke (AIS) patients receiving endovascular therapy (EVT). The main questions it aims to answer are:
- Evaluating the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function after EVT.
- Evaluating the safety of high and low normobaric oxygen concentration in patients with ischemic stroke.
Participants will (1) receive EVT under general anesthesia; (2) be randomly assigned 1:1 to receive oxygen therapy with FiO2=80% or FiO2=30% through endotracheal intubation during the operation, and the gas flow rate was set at 4L /min.
详细描述
The optimal fraction of inspired oxygen (FiO2) during EVT under general anesthesia is currently uncertain. This is a randomized controlled trial (RCT) designed to assess the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function following EVT. It is a prospective, open-label, parallel-design RCT planned to be conducted at Beijing Tiantan Hospital, Capital Medical University. It is anticipated that 200 cases of AIS patients undergoing EVT under general anesthesia will be consecutively enrolled from 2024 to 2026. Eligible participants will be randomly assigned in a 1:1 ratio. After general anesthesia induction, patients will receive continuous inhalation of oxygen with either FiO2=80% or FiO2=30% through endotracheal intubation until the end of the procedure, with a gas flow rate set at 4 L/min. The positive end-expiratory pressure (PEEP) is uniformly set to 5 cmH2O to balance its effect on pulmonary oxygen delivery. The primary outcome will be the occurrence of early neurological improvement (NIHSS score of 10 points 24±2 hours after EVT). Safety outcomes include potential adverse events such as site infection, three-month mortality, etc.
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
- Triple (Participant, Investigator, 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
- •Age ≥18 years.
- •Anterior circulation occlusive stroke is confirmed by CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA), and occlusions of intracranial internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA) were involved.
- •NIHSS score at admission: 6-
- •Randomization can be completed within 24 hours after stroke onset.
排除标准
- •Stroke onset within 6-24 hours with a CT perfusion imaging (CTP)-assessed mismatched area<15 ml.
- •Presence of anemia, defined as hemoglobin levels o below 120 g/L in men and below 110 g/L in women.
- •Pre-stroke modified Rankin scale (mRS) score ≥
- •Complicated by severe agitation and seizures.
- •Evidence of intracranial hemorrhage at admission.
- •Presence of chronic obstructive pulmonary disease, asthma, or other respiratory conditions, or requirement for daily supplemental oxygen or mechanical ventilation.
- •Baseline arterial blood gas analysis indicating impaired gas exchange: PaO2 < 60 mmHg on room air, or oxygenation index (PaO2/FiO2) < 300 mmHg with supplemental oxygen.
- •Emergency chest CT reveals significant pulmonary parenchymal infection.
- •An oxygen mask or ventilator must be used before anesthesia to maintain a SpO2≥94%.
- •Loss of airway protective reflex or vomiting aspiration upon admission.
研究组 & 干预措施
Normobaric high-concentration oxygen (NBHO) group
After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 µg/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBHO group will adjust the FiO2 at 80% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 µg/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed.
干预措施: Normobaric high-concentration oxygen (Other)
Normobaric low-concentration oxygen (NBLO) group
After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 µg/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBLO group will adjust the FiO2 at 30% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 µg/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed.
干预措施: Normobaric low-concentration oxygen (Other)
结局指标
主要结局
the incidence of early neurological improvement (ENI)
时间窗: 24±2 hours after EVT
ENI is defined as an NIHSS score of \<10 points at 24±2 hours after EVT
次要结局
- ΔNIHSS at 24±2 hours after EVT(24±2 hours after EVT)
- the final infarct volume(72 hours post-randomization)
- early neurological deterioration (END)(1 day after reperfusion therapy)
- Postoperative pulmonary complications(within 7 days after endovascular therapy)
- overall mRS distribution at 90 days(90 days after stroke onset)
- favorable functional outcome(90 days after stroke onset)
研究者
Ruquan Han
Lead Investigator
Beijing Tiantan Hospital