Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Area under curve of regional cerebral oxygen saturation (rSO2) curve
研究概览
简要总结
This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.
详细描述
High inspired oxygen concentration may reduce brain hypoxia in the patients undergoing carotid endarterectomy with total intravenous anaesthesia. However, there are some studies suggesting that high inspired oxygen concentration may induce cerebral vasoconstriction. This study was performed to measure the influence of fraction of inspired oxygen (FiO2) on the regional tissue oxygenation in the patients undergoing carotid endarterectomy with total intravenous anaesthesia. The INVOS 5100B monitor was used for regional cerebral oxygen saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool (Covidien) for area under curve (AUC) calculations. A bispectral index and invasive blood pressure monitoring were used in all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient undergoing surgery (carotid endarterectomy)
排除标准
- •decompensated and uncontrolled respiratory and cardiac disease, myocardial infarction suffered in the last 6 months, cerebrovascular infarction, coagulopathy, anaphylaxis to drugs
研究组 & 干预措施
100% O2
Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration
干预措施: Oxygen concentration (Procedure)
35% O2
Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration
干预措施: Oxygen concentration (Procedure)
结局指标
主要结局
Area under curve of regional cerebral oxygen saturation (rSO2) curve
时间窗: During surgery
Intraoperative high oxygen concentrations may reduce intensity of tissue hypoxic episodes during carotid endarterectomy in total intravenous anesthesia (TIVA). The INVOS 5100B monitor was used for regional cerebral oxygen saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool (Covidien) for Area under curve (AUC) calculations. Data were analyzed using two sided T-test and Fisher exact test. A P\<0.05 was considered as statistically significant Postoperative follow up in large patient's group is necessary to confirm its impact on patients' outcome.
次要结局
- Intensive Care Unit admission, Death(Till 7 days after surgery)
- Early neurologic recovery, TIA or brain ischemia(Till 7 days after surgery)
研究者
Vedran Gašić, MD
Vedran Gasic, M.D.
Osijek University Hospital