NCT06133842招募中不适用
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State - CERBERUS Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CA state and lower limits of autoregulation (LLA):
研究概览
简要总结
The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question[s] it aims to answer are:
- Is there a way to tailor the blood pressure to be maintained in such patients during surgery for optimal brain health using non-invasive monitors that check the brains electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood oxygen levels, the cerebral oximetry(CO) monitor?
- How much does this optimal blood pressure level vary between patients?
Participants will be asked to:
- Complete a questionnaire at the time they enroll into the study, as well as a daily questionnaire to help determine their level of thinking and brain health. This questionnaire will be administered by a member of the study team.
- They will also have an EEG and CO monitoring sticker placed on their foreheads. This will be connected to a monitor that will collect this data just before, during, and after their surgery. The data collected through these monitors will help us with our study goals.
详细描述
Study Procedures:
Pre-operative:
- Assessment by an anesthesiologist, and brief patient education about cerebral autoregulation and post-operative delirium.
- MOCA baseline cognitive assessment by study team member.
Intra-operative:
- Perioperative EEG Monitoring: EEG stickers will be applied to patient's forehead in pre-op holding area and attached to SedLine Root Monitor (described below in perioperative EEG and Cerebral Oximetry10 (CO) monitoring) at least 5 minutes prior to start of induction.
- Perioperative CO monitoring: NIRS stickers will be applied to patient's forehead in pre-op holding area and attached to SedLine Root Monitor (described below in perioperative EEG and Cerebral Oximetry (CO) monitoring) at least 5 minutes prior to start of induction.
- Live collection and processing of data: During surgery, the SedLine Root Monitor (which collects EEG & CO data) and the Operating Room's en-suite Phillips Intellivue monitor (which collects MAP data during surgery) will both be connected to a BIDMC-issued, IS-approved laptop or tablet running the ICM+ software suite. The SedLine Root Monitor and Philips Intellivue Monitor will output their data locally via cables to the system running the ICM+ software suite, which will process and integrate this data in real-time. This processed information will only be collected passively during the surgery, and will not inform or affect clinical care in any way.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 60 years
- •Undergoing any non-cardiac surgeries including but not limited to vascular, hepatobiliary, or complex spine surgeries requiring general anesthesia with arterial catheterization for monitoring
排除标准
- •Non-English speaking (Justification: cognitive assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
- •Cognitive impairment as defined by total MoCA score < 10 (justification: baseline cognitive dysfunction will confound primary outcome measure)
- •Significant visual impairment (justification: will be difficult for patients to draw individual components in MOCA score)
- •Emergent surgery (justification: insufficient time to initiate intervention)
- •History of stroke within the last 3 months (justification: cognitive dysfunction secondary to stroke can confound outcome measures
结局指标
主要结局
CA state and lower limits of autoregulation (LLA):
时间窗: 1 week
The primary outcome will be reliability in the form of an "uptime". This is a calculation of the percentage that each signal provides a feasible measurement, and a percentage that each method of autoregulation calculation produces an output. Previous studies have demonstrated a high frequency of uptime, upwards of 90%. CA state and lower limits of autoregulation (LLA) will be calculated using two distinct methods, both previously published and enumerated in the Statistical Consideration section
次要结局
- Duration of burst suppression in EEG(1 week)
- Incidence of Postoperative Delirium (POD)(Within 1 week)
- Cognitive function(1 month and 6 months)
- Hemodynamic stability - Vasopressor Usage(1 week)
- Hemodynamic stability - Time outside ideal systolic range(1 week)
- Hemodynamic stability - Area Under Curve(1 week)
- Hemodynamic stability - Coefficient of Variation recorded as a simple integer(1 week)
研究者
Samir Kendale
Assistant Professor of Anaesthesia at the Harvard Medical School, Director of Neuroanesthesia at BIDMC
Beth Israel Deaconess Medical Center
研究点 (1)
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