Study to evaluate and compare the regional cerebral oxygenation levels using Near Infrared Spectroscopy during perioperative period in patients undergoing endovascular coiling or surgical clipping of intracranial aneurysm.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Regional cerebral oxygenation levels during intraoperative and initial postoperative period for six hours in patients undergoing endovascular coiling or surgical clipping
研究概览
简要总结
Aneurysmal subarachnoid hemorrhage (aSAH) after rupture of an intracranial aneurysm may lead to cerebral hypoxia which can have profound adverse outcomes like stroke, focal neurological impairment, delayed cerebral ischemia, and prolonged neuro-intensive care unit and hospital stays. As cerebral hypoxia can potentially develop during aneurysm clipping and coiling, monitoring of cerebral oxygen levels are thus essential for early detection and timely management of cerebral hypoxia to enable improved outcomes in aSAH patients.
We aim to compare the regional cerebral oxygenation (rSO2) levels using Near Infrared Spectroscopy (NIRS) during peri-operative period in patients undergoing endovascular coiling or surgical clipping of intracranial aneurysm and to correlate its impact on postoperative neurological outcome.
To treat a critical reduction in cerebral oximetry values (these interventions will be done only when rSO2 level achieves a critical threshold (rSO2<20% from baseline) oxygen delivery and oxygen consumption will be optimized.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with aneurysmal subarachnoid hemorrhage of anterior circulation posted for endovascular coiling or surgical clipping.
排除标准
- •Patients with with posterior circulation aneurysm, ASA physical status V and VI, Pre-existing chronic neurologic disease, Moderate and severe systolic dysfunction (Ejection fraction less than 40%), Severe valvular stenosis (aortic or mitral), Unoptimized circulatory shock, Severe anaemia.
结局指标
主要结局
Regional cerebral oxygenation levels during intraoperative and initial postoperative period for six hours in patients undergoing endovascular coiling or surgical clipping
时间窗: Baseline values before administration of any drug | Every 5minutes till the patient is either extubated or shifted out of operation theatre intubated | Every 15 minutes till 6 hours postoperatively
次要结局
- Area under curve of regional cerebral oxygenation levels below 10% from baseline(Baseline values before administration of any drug)
- Correlation of regional cerebral oxygenation levels with-(the occurrence of delayed cerebral ischemia)
研究者
Dr Nupur Khewle
GIPMER