Perioperative Interventions to Optimize Cerebral Oxygen Saturation (rSO2) in High-risk Patients Undergoing Cardiac Surgery Should Have a Beneficial Systemic Effect for Enhancing Global Tissue Perfusion and Improve Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Success rate of reversing decreases in cerebral oxygen saturation below 10% of baseline values to values within 10% of baseline in the INTERVENTION group.
研究概览
简要总结
Using the brain and the heart as index organs, perioperative interventions to optimize cerebral oxygen saturation and cardiac contractility in high-risk patients undergoing cardiac surgery should have a beneficial systemic effect for enhancing global tissue perfusion and improve outcomes.
详细描述
The proportion of high-risk patients requiring cardiac surgery and of high-risk cardiac surgeries is increasing. These populations of patients are at increased risk of perioperative morbidity and mortality. Transesophageal echocardiography (TEE) evaluation in cardiac surgery has been shown to impact on the perioperative management of patients and to improve outcomes. Near infrared-reflectance spectroscopy (NIRS) is a technique that has been employed since the mid-1970's and that can be used as a non-invasive and continuous monitor of the balance between cerebral oxygen delivery and consumption. Two recent randomized trials have shown an association between correction of cerebral desaturation and shorter recovery room and hospital stay in non-cardiac surgery, and with a decrease in major organ dysfunction and in intensive care length of stay after coronary artery bypass. By combining NIRS and TEE in high-risk patients, optimal tissue perfusion could be achieved and perioperative morbidity and mortality could be reduced.
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
- None
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
- •Patients with EUROSCORES ≥
- •Planned complex surgery including more than one procedure, or redo procedures.
- •Patient able to read and understand the consent form.
- •Patients ≥ 18 years of age.
排除标准
- •High risk patients undergoing of off pump coronary artery bypass.
- •Emergency surgeries less than 6 hours from diagnosis.
- •Patient unable to read and understand the consent form.
- •Patients with and IABP or a ventricular assist device
- •Planned circulatory arrest
- •Planned surgery of the descending aorta.
- •Patients with acute endocarditis.
结局指标
主要结局
Success rate of reversing decreases in cerebral oxygen saturation below 10% of baseline values to values within 10% of baseline in the INTERVENTION group.
时间窗: Up to 12 hours
Consensus on the appropriate strategies to prevent and reverse cerebral oxygen desaturations remains controversial. In a recent study by Slater and al.12, randomization into an intervention group failed because anesthesiologists were unable to follow the protocol aimed at strategies to reverse decreases in rSO2. A group from the Montreal Heart Institute has developed a physiologically oriented algorithm to help with the task of reversing decreases in rSO2. The goal of the present study is therefore to confirm that this approach can be used with success by most institutions.
次要结局
- First 30 days post-operative outcomes(30 days)
- Post-operative complications(Up to 7 days)
- First 24 hours complications(24 hours)
- ICU data(Up to 48 hours)
研究者
Alain Deschamps
PhD, MD, FRCPC,
Montreal Heart Institute