Cerebrovascular Autoregulation During Major Non-cardiac Surgery - a Comparison Between Near Infrared Spectroscopy and Transcranial Doppler Sonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 509
- 试验地点
- 1
- 主要终点
- Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulation
研究概览
简要总结
Postoperative neurocognitive disorders (NCD) are of high priority in perioperative management. The risk of suffering from NCD after surgery may be increased due to perioperative impairment of cerebrovascular autoregulation and thereby inadequate cerebral perfusion. Cerebrovascular autoregulation refers to the ability of cerebral arterioles to ensure constant cerebral blood flow independently of fluctuations in systemic blood pressure.
Cerebrovascular autoregulation can be measured based on mean arterial pressure (MAP) and a surrogate for cerebral blood flow using the correlation method. Until today, measurement of cerebral blood flow velocity assessed with transcranial Doppler sonography (TCD) is most commonly used as a non-invasive surrogate for cerebral blood flow. Alternatively, cerebral oxygenation measured with near-infrared spectroscopy (NIRS) can be used as another surrogate.
The study includes three substudies:
- To compare NIRS and TCD for the assessment of perioperative cerebrovascular autoregulation in patients undergoing major non-cardiac surgery with an increased risk of bleeding.
- To compare MAP for optimal cerebrovascular autoregulation before induction of general anesthesia with MAP for optimal cerebrovascular autoregulation during or after general anesthesia.
- To analyze the association between the time-weighted average MAP below the MAP for optimal cerebrovascular autoregulation and postoperative NCD.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Elective surgery with a minimum duration of 120 minutes
- •General anesthesia
- •expected blood loss > 500 ml
排除标准
- •Temporal bone window failure (substudy 1)
- •Cerebrovascular disease
- •Cardiac surgery
- •Neurosurgery
结局指标
主要结局
Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulation
时间窗: up to 4 hours during surgery
calculation of cerebral autoregulation indices based on near-infrared spectroscopy and transcranial Doppler sonography
optimal MAP during NIRS-based measurement of cerebrovascular autoregulation
时间窗: up to 2 hours after surgery
MAP at lowest cerebral autoregulation index COx
delirium and postoperative NCD after surgery (composite)
时间窗: days 1 to 4 after surgery (delirium), day 7 after surgery or at day of discharge from hospital (NCD)
screening for postoperative delirium; neuropsychological testing for the assessment of cognitive function
次要结局
- optimal MAP during TCD-based measurement of cerebrovascular autoregulation(up to 4 hours during surgery)
- postoperative delirium between day 1 and 4 after surgery(days 1 to 4 after surgery)
- delayed neurocognitive recovery at day 7 after surgery or before hospital discharge(day 7 after surgery or at day of discharge from hospital)
- length of hospital stay(date of discharge from hospital (up to 30 days))
- length of ICU stay(date of discharge from ICU (up to 30 days))
- mortality at 3 months after surgery(3 months after surgery)