Evaluation of the Effect of Moderate and Controlled Hypercapnia on Ischemic Penumbra Vascular Collaterality During General Anesthesia for Anterior Circulation Acute Ischemic Stroke Mechanical Thrombectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- ASITN cerebral vascular collaterality score > 2
研究概览
简要总结
Acute ischemic stroke due to large vessel occlusion is responsible of cerebral blood flow impairment with a progressive and extensive ischemic process. Cerebral collateral circulation may preserve an ischemic penumbra that could recover providing timely reperfusion of the occluded vessel. Mechanical thrombectomy is the standard of care for anterior circulation large vessel reperfusion. Strategy to promote cerebral blood flow in collateral circulation before reperfusion is scarce and rely mainly on blood pressure maintenance. Carbon dioxide is a potent cerebral vasodilator that could enhance collateral circulation blood flow and cerebral protection before reperfusion. General anesthesia with endotracheal mechanical ventilation could be used for thrombectomy and give the opportunity to modulate and control carbon dioxide tension in the blood. This study will test the effect of moderate hypercapnia on penumbral collateral circulation before reperfusion during mechanical thrombectomy for anterior circulation acute ischemic stroke under general anesthesia.
详细描述
Study will compare 2 groups of patients treated for anterior circulation large vessel occlusion stroke thrombectomy under general anesthesia.
After anesthetic evaluation, patients will be randomized to receive moderate hypercapnia targeting an arterial CO2 tension (PaCO2) of 50mmHg or normocapnia targeting a PaCO2 of 40mmHg.
The anesthetic protocol will use:
- Rapid sequence induction for orotracheal intubation with PROPOFOL 2mg/Kg and SUXAMETHONIUM 1mg/Kg
- SUFENTANIL 0,1 µg/Kg and CISATRACURIUM 0,1mg/Kg
- Maintenance with intravenous continuous infusion of PROPOFOL targeting a BISpectral index 40 to 60
- Systolic blood pressure will have to be maintained +/- 10% of preoperative baseline value with limits between 120 and 185mmHg (with NOREPINEPHRINE as needed)
- Mechanical ventilation will use Tidal Volume of 7mL/Kg of ideal body weight, respiratory rate of 15/minute, End expiratory pressure of 5cmH2O. FiO2 will target SpO2 95-98%. Initial End Tidal CO2 (EtCO2) target will be 35mmHg.
- A first arterial blood gas analysis at groin puncture will evaluate CO2 alveolar-arterial gradient in order to obtain the expected PaCO2 in each group with respiratory rate modulation on the ventilator.
- ASITN baseline collaterality score will be evaluated at initial angiography with normocapnia in each group. A second evaluation of ASITN will be done just before deployment of intraarterial revascularisation device in hypercapnia or normocapnia depending on randomisation group.
- Targeted PaCO2 will have to be maintained using EtCO2 surrogate until the end of procedure.
- A second arterial blood gas analysis at the end of procedure will evaluate final PaCO2.
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
- Double (Participant, 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
- •Large vessel occlusion anterior circulation stroke (terminal carotid artery and/or middle cerebral artery M1-M2 segment) eligible to mechanical thrombectomy under general anesthesia
排除标准
- •Active smoker
- •Chronic respiratory failure with ambulatory oxygen supplementation
- •Obesity with BMI>40Kg/ m2
- •Intubation before the procedure
- •Heart failure with intolerance to decubitus
- •Severe renal failure
- •Suspected elevated intracranial pressure
- •Pregnant or breastfeeding women
研究组 & 干预措施
NORMOCAPNIA
Under general anesthesia with mechanical ventilation, PaCO2=40mmHg will be targeted
干预措施: NORMOCAPNIA (Biological)
HYPERCAPNIA
Under general anesthesia with mechanical ventilation, PaCO2=50mmHg will be targeted
干预措施: HYPERCAPNIA (Biological)
结局指标
主要结局
ASITN cerebral vascular collaterality score > 2
时间窗: Before reperfusion of the occluded vessel
American Society of Interventional and Therapeutic Neuroradiology (ASITN) cerebral vascular collaterality score ranges from 0 (no collaterals visible to the ischemic site) to 4 (complete and rapid collateral blood flow to the vascular bed in the entire ischemic territory by retrograde perfusion). A score \> 2 indicate at least collaterals with slow but complete angiographic blood flow of the ischemic bed by the late venous phase.
次要结局
- ASITN cerebral vascular collaterality score(• At initial angiography in normocapnia and • Before reperfusion at randomized arterial CO2 tension level)
- Volume of cerebral infarction(24 hours after stroke)
- Neurological clinical outcome(3 months)
- Progression of cerebral infarction(24 hours after stroke)