A Prospective Study of Cerebral Oximetry to Assess Symmetry of Cerebral Blood Flow and Clinical Outcomes in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of asymmetrical cerebral desaturation
研究概览
简要总结
Cerebral oxygen desaturation during cardiac surgery measured using near infrared spectroscopy (NIRS) derived cerebral oximetry has been associated with significant postoperative morbidity. If significant desaturation occurs during this period, it may represent an ideal opportunity to further optimize the postoperative care of these patients.
详细描述
Selective antegrade cerebral perfusion (SACP) is a commonly used technique for maintaining cerebral blood flow (CBF) during the use of hypothermic cardiac arrest (HCA) for aortic arch reconstruction. However, even with an intact Circle of Willis, asymmetric CBF is a common occurrence during HCA when SACP is used. The investigators have previously shown that ultrasound guided extrinsic compression of the left carotid artery can increase left cerebral oxygen saturation, and improved symmetry of CBF; however, this has not been investigated formally. In this study, the investigators will firstly formally assess the incidence and severity of asymmetrical cerebral flow between the left and right hemispheres in patients undergoing aortic arch repair (n=20). CBF will be assessed indirectly through regional cerebral oxygen saturation (rSO2) measured via near-infrared spectroscopy-derived cerebral oximetry. In addition, a number of clinical outcome parameters (up to 30 days post-op) will be evaluated. The investigators expect that significant left-side cerebral hypoperfusion will consistently be observed in patients undergoing aortic arch repair using SACP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Age 18 years or older
- •Surgery requiring cardio pulmonary bypass
- •Ascending aorta or arch repair surgery
- •Surgery requiring hypothermic circulatory arrest
排除标准
- •Off-pump cardiac surgery
- •Skin condition preventing the use of cerebral oximetry pads
结局指标
主要结局
Incidence of asymmetrical cerebral desaturation
时间窗: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
Cerebral desaturation defined as a greater than 10% difference in cerebral saturation comparing one hemisphere to the other based on a baseline reading taken in the minute preceding the onset of HCA to the end of the hypothermic period.
次要结局
- All cause mortality(Surgical induction to 30 day postoperative)
- Neurologic injury(Surgical induction to 30 day postoperative)
- Renal injury(Surgical induction to 30 day postoperative)
- Gastrointestinal morbidity(Surgical induction to 30 day postoperative)
- Serious infection(Surgical induction to 30 day postoperative)
- Renal function(Preoperative to hospital discharge or 30 days postoperative, whichever comes first)
- Nausea and vomiting(ICU admission to hospital discharge or 30 days postoperative, whichever comes first)
- Myocardial infarction(ICU admission to hospital discharge or 30 days postoperative, whichever comes first)
- Atrial and/or ventricular arrhythmia(ICU admission to hospital discharge or 30 days postoperative, whichever comes first)
- Severity of asymmetrical cerebral desaturation(Duration of hypothermic circulatory arrest between surgical induction and ICU admission)
- In-hospital mortality(Surgical induction to hospital discharge or 30 days postoperative, whichever comes first)
- Hospital length of stay(Surgical induction to hospital discharge or 30 days postoperative, whichever comes first)
- ICU length of stay(ICU admission to ICU discharge or 30 days postoperative, whichever comes first)
- Transfusions(Surgical induction to hospital discharge or 30 days postoperative, whichever comes first)
- Intubation time(Time of surgical intubation to time of extubation)
- Hemostatic support(ICU admission to hospital discharge or 30 days postoperative, whichever comes first)
- Atrial fibrillation(ICU admission to hospital discharge or 30 days postoperative, whichever comes first)