Validation of Cerebral Non-invasive Monitoring and Prediction of Post-operative Delirium and Outcomes: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Rate of neurological events
研究概览
简要总结
Brain monitoring using near-infrared spectroscopy (NIRS) started in 2002 in the operating room of the Montreal heart Institute (MHI). This was followed by the use of somatic NIRS in 2010, transcranial Doppler in 2015 and processed electroencephalogram (pEEG) using Sedline (Masimo, Irvine CA) in 2017. The introduction of those modalities led to significant change in intraoperative management. The goal of these devices is to improve our ability to detect and predict post-operative complications as well as offering insights on how to prevent them. The current project explores in further detail the impact of the introduction of pEEG in the operating room and in the intensive care unit (ICU) on post-operative delirium.
详细描述
Overview of the problem: Post-operative delirium in cardiac surgery Brain monitoring using NIRS started in 2002 in the operating rooms of the MHI. Since that period, the investigators described our experience on 1613 reported patients from published case reports (n=30), cohort studies (n=1270), randomized controlled trials (n=313), and review articles.
In the presence of brain desaturation, the investigators have previously described an algorithmic approach based on a series of interventions (such as head positioning, increasing blood pressure and inspired oxygen etc.) which are triggered by the etiology, one at a time or simultaneously, ideally as early as possible i.e. when the cerebral NIRS value start to decrease by more than 10%. The success rate for correction of brain desaturation was more than 95%.
The use of both cerebral NIRS and pEEG led to new insights which were not apparent when these technologies were used in isolation. For instance, brain desaturation resulting from increased pEEG activity will be observed upon awakening. On the other hand, brain desaturation associated with reduced pEEG activity may indicates brain hypoperfusion. A new algorithm to manage cerebral NIRS and pEEG was introduced and published in May 2019.
This algorithm has not been validated and could represent a major advance in the care of cardiac surgical patients. One of the potential roles of this type of monitoring would be its ability to predict emergence delirium, postoperative delirium and other end-organ complications. Eventually, the early identification could lead to prevention of post-operative complications such as delirium.
Brain oximetry and delirium Between 16% and 30% of elderly hospitalised patients with cardiovascular disease will develop delirium. Delirium and cognitive dysfunction are highly frequent among hospitalized patients across all healthcare settings, but especially in surgical and critical care populations where rates are reported to be as high as 70%. Mortality is increased in patients with delirium after cardiac surgery.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, age 18 and older, undergoing cardiac surgery with CPB or off pump CABG
排除标准
- •Patient with a critical pre-operative state defined as any of the following: vasopressor requirement, mechanical circulatory support, dialysis, mechanical ventilation, cardiac arrest necessitating resuscitation, aborted sudden death, preoperative cardiac massage, preoperative intra-aortic balloon pump.
- •Patient with the diagnosis of delirium at any point before surgery during the current hospitalization
- •Emergent surgery
- •Surgery under deep hypothermic circulatory arrest
结局指标
主要结局
Rate of neurological events
时间窗: 72 hours
Events will be categorized according to change in oxygen saturation measured by near infra-red spectroscopy and according to changes in pEEG activity evaluated by the patient state index, burst suppression ratio and spectral edge frequency. Events will be categorized based on the following classification: 1. Cerebral desaturation (\>10% from baseline) AND a decrease in pEEG activity (patient state index (PSI) \< 40 and/or burst suppression ratio (BSR) \>0 and/or spectral edge frequency (SEF) \<10) 2. Cerebral desaturation (\>10% from baseline) AND an increase in pEEG activity (PSI ≥ 60, BSR = 0, SEF \> 15) 3. Cerebral desaturation (\>10% from baseline) AND a normal pEEG activity (PSI ≥ 40-60, BSR = 0 and SEF 10-15) 4. Normal cerebral saturation (Cerebral desaturation ≤10% from baseline) AND a decrease in pEEG activity (PSI \< 40, and/or BSR \>0 and/or SEF\<10).
次要结局
- Rate of cognitive dysfunction(72 hours)
- Rate of delirium(72 hours)
- Rate of all cause death during hospitalization(Up to 30 days or until hospital discharge)
- Rate of major bleeding(Up to 30 days or until hospital discharge)
- Rate of surgical re-intervention(Up to 30 days or until hospital discharge)
- Duration of persistent organ dysfunction(Up to 28 days or until hospital discharge)
- Rate of acute kidney injury(Up to 30 days or until hospital discharge)
- Duration of mechanical ventilation(Up to 30 days or until hospital discharge)
- Rate of stroke(Up to 30 days or until hospital discharge)
研究者
Andre Denault
Principal Investigator
Montreal Heart Institute