Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Mean Cerebral Perfusion Pressure (CPP, mmHg)
研究概览
简要总结
Across broad surgical populations, cerebral hypoperfusion is associated with increased mortality, stroke, brain cellular injury, and poor functional outcomes. Based on available evidence, The Brain Trauma Foundation recommends that cerebral perfusion pressure (CPP) be maintained greater than 60 mmHg in high-risk settings to minimize risk of cerebral ischemia. Though several lines of investigation have focused on optimal cerebrovascular management in the intensive care unit and cardiac surgery settings, much less focus has been placed on cerebrovascular management during non-cardiac surgery.
Preliminary data indicate that intraoperative CPP routinely falls below 60 mmHg in neurosurgical and trauma surgery settings, though the relationship between reduced intraoperative CPP and outcomes remains unclear. Furthermore, effective methods by which low intraoperative CPP could be prevented have not been thoroughly investigated, which represents the first required step prior to studying the relationship between intraoperative CPP and clinical outcomes. Thus, the aim of this study is to evaluate the efficacy of an automated algorithm that alerts clinicians to a decrease in CPP below 60 mmHg. This study tests the hypothesis that an automated pager alert system (triggered by CPP falling below 60 mmHg) will increase intraoperative CPP compared to standard of care.
详细描述
This will be a single-center study taking place at the University of Michigan Health System, Ann Arbor, MI. The study has been approved by the University of Michigan Medical School Institutional Review Board (IRBMED).
Automated pager alert protocols have been previously published from the investigators' department, and this alerting system is used for operational purposes on a daily basis. Surgical patients will be automatically screened using a designed script from the anesthesia information management system (Centricity, Wishahaka, WI).
The script will screen for active surgical patients with intracranial pressure (ICP) data recording in our hospital's non-cardiac operating rooms. When these data are captured, an automated enrollment process will occur if the following electronic charting criteria are met:
- Age ≥ 18 years old
- Case identified as a general anesthetic
- Non-intracranial aneurysm surgery
- Non-pregnant patient
After "anesthetic induction end" time is documented within the case, the alerting system will turn on after a 10-minute grace period. The alerting system will then retroactively measure median CPP values over 5-minute epochs, and if median CPP is < 60 mmHg, the following alphanumeric pager alert will be delivered:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adult (≥18 years old) surgical patients
- •Intracranial pathology requiring intracranial pressure (ICP) monitoring
排除标准
- •Intracranial aneurysm surgery
- •Cases with pressures monitored from a lumbar drain
- •Cardiac surgery cases
- •Enrolled in conflicting study
- •Pregnancy
结局指标
主要结局
Mean Cerebral Perfusion Pressure (CPP, mmHg)
时间窗: Assessed intraoperatively for the duration of the CPP monitoring period
次要结局
- Myocardial Infarction (incidence, %)(Within 30 days of surgery)
- Congestive Heart Failure (incidence, %)(Within 30 days of surgery)
- Acute Kidney Injury, AKI (incidence, %)(Within 30 days of surgery)
- Mortality (incidence, %)(Within 30 days of surgery)
- Acute Respiratory Distress Syndrome, ARDS (incidence, %)(Within 30 days of surgery)
- Postoperative Stroke (incidence, %)(Within 30 days of surgery)
- Cardiac Dysrythmias (incidence, %)(Within 30 days of surgery)
研究者
Phillip Vlisides
Assistant Professor of Anesthesiology
University of Michigan