Association of Intraoperative Blood Viscosity With Cerebral Oxygenation and Postoperative Composite Complications in Adults Undergoing Elective Intracranial Craniotomy: A Prospective Observational Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of participants with one or more postoperative composite complications within 30 days after surgery
概览
简要总结
This prospective observational study aims to evaluate the association between intraoperative blood viscosity and postoperative clinical outcomes in adult patients undergoing elective intracranial craniotomy.
Blood viscosity is an important determinant of microcirculatory flow and cerebral perfusion, but its role in perioperative outcomes remains unclear. In this study, intraoperative blood viscosity and related hematologic parameters will be measured, and their relationships with cerebral oxygenation and postoperative complications will be analyzed.
The study will enroll adult patients undergoing elective intracranial surgery at a single tertiary center. The findings of this study may improve understanding of perioperative hemodynamic and hemorheological factors and help identify potential risk markers for adverse postoperative outcomes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 years
- •Patients scheduled to undergo elective intracranial craniotomy
- •Patients requiring intraoperative arterial catheterization and routine arterial blood gas analysis
- •Patients who provide written informed consent
排除标准
- •Emergency surgery
- •Patients in whom participation or follow-up is considered difficult by the investigator
- •Patients unable to provide informed consent
研究组 & 干预措施
Elective Intracranial Craniotomy Patients
Adult patients undergoing elective intracranial craniotomy who are prospectively enrolled
干预措施: Observational Assessment of Blood Viscosity (Other)
结局指标
主要结局
Number of participants with one or more postoperative composite complications within 30 days after surgery
时间窗: Up to postoperative day 30
Composite complication is defined as the occurrence of at least one of the following within 30 days after surgery: postoperative neurologic complications, respiratory complications, cardiovascular complications, acute kidney injury defined as Kidney Disease Improving Global Outcomes stage 1 or higher, infectious complications requiring intravenous antibiotics or a procedure, reoperation or major postoperative intervention, or death.
次要结局
- Change in high-shear blood viscosity from after induction of anesthesia to near the end of surgery(After induction of anesthesia and near the end of surgery)
- Change in low-shear blood viscosity from after induction of anesthesia to near the end of surgery(After induction of anesthesia and near the end of surgery)
- Change in TODI from after induction of anesthesia to near the end of surgery(After induction of anesthesia and near the end of surgery)
- Intraoperative regional cerebral oxygen saturation desaturation burden(From after induction of anesthesia to end of surgery)
- Area under the predefined regional cerebral oxygen saturation desaturation threshold curve during surgery(From after induction of anesthesia to end of surgery)
- Number of participants with postoperative neurologic complications within 30 days after surgery(Up to postoperative day 30)
- Number of participants with postoperative respiratory complications within 30 days after surgery(Up to postoperative day 30)
- Number of participants with postoperative cardiovascular complications within 30 days after surgery(Up to postoperative day 30)
- Number of participants with acute kidney injury within 30 days after surgery(Up to postoperative day 30)
- Number of participants with postoperative infectious complications within 30 days after surgery(Up to postoperative day 30)
- Number of participants requiring reoperation or major postoperative intervention within 30 days after surgery(Up to postoperative day 30)
- Number of participants with all-cause mortality within 30 days after surgery(Up to postoperative day 30)
研究者
Ji-Hoon Sim
Assistant Professor
Asan Medical Center