Reducing Delirium After Cardiac Surgery: Personalized Targeted Blood Pressure Management Strategy Using Cerebral Autoregulation Monitoring: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Recruitment rate
研究概览
简要总结
Approximately one in four elderly patients develops postoperative delirium (POD) after cardiac surgery. POD is associated with prolonged hospitalization, increased mortality, and higher health care costs. While patient-related risk factors are often difficult to modify, surgery- and anesthesia-related factors may be optimized to reduce the incidence of POD. One potentially modifiable factor is intraoperative blood pressure management. Current practice commonly relies on standardized blood pressure targets during cardiac surgery; however, this "one-size-fits-all" approach may not account for individual variability in cerebral perfusion requirements. This study proposes a personalized blood pressure management strategy based on real-time monitoring of cerebral autoregulation, with the goal of maintaining optimal cerebral perfusion and protecting the brain from both hypo- and hyper-perfusion
详细描述
The primary aim of this pilot study is to evaluate the feasibility of conducting a subsequent definitive trial by assessing recruitment rates, protocol adherence, and the completeness and quality of short-term outcome data collection. The pilot study will also provide an opportunity to identify potential challenges and optimize the design of the larger trial, if necessary.
If the study hypothesis is confirmed and subsequently reproduced in larger, rigorous clinical trials, the findings could have important implications for intraoperative blood pressure management in elderly patients undergoing cardiac surgery. Specifically, this research may support a transition from the current "one-size-fits-all" blood pressure management strategy toward an individualized, real-time approach guided by cerebral autoregulation monitoring. Such a personalized strategy could potentially reduce the incidence of postoperative delirium (POD) in this high-risk population.
Conversely, premature implementation of personalized blood pressure management based solely on the currently available preliminary evidence may lead to unintended adverse consequences. Therefore, the proposed pilot study is essential to provide critical feasibility and safety data before proceeding to a larger definitive trial.
This study will be conducted as a prospective, single-centre, randomized controlled clinical trial comparing a real-time cerebral autoregulation monitoring-based blood pressure management strategy with standard care. Participants will be randomized into two groups:
Intervention Group: Blood pressure management guided by real-time cerebral autoregulation monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Intervention group or the control group (1:1 ratio). Prior to anesthesia induction, bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area of all patients. In the intervention group, cerebral autoregulation will be monitored intra-operatively for the duration of surgery. In the control group, the cerebral oximetry monitor will be electronically blinded, but data will be continuously recorded and stored for later analysis.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients aged ≥ 60 years undergoing elective complex cardiac surgery (coronary artery bypass grafting plus valve surgery, double-valve surgery, triple-valve surgery, redo operations, or aortic arch surgery), or patients aged ≥ 70 years undergoing isolated coronary artery bypass grafting or single-valve repair/replacement surgery.
排除标准
- •Patients with symptomatic cerebrovascular disease.
- •History of delirium.
- •Major neurocognitive impairment (e.g., dementia or Mini-Mental State Examination score < 10).
- •Schizophrenia.
结局指标
主要结局
Recruitment rate
时间窗: 2 year
1\. Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: \>10%).
Non-adherence with the protocol
时间窗: 2 year
Non-adherence with the protocol (percentage of patients with VRx \> 0.3 where no intervention was performed; \<10%)
Completeness and quality of POD assessment
时间窗: 2 year
Completeness and quality of POD assessment (percent of patients for whom all CAM-ICU assessments are complete and conclusive; \> 90%)
次要结局
- Overall incidence of impaired cerebral autoregulation(2 year)
- Percentage of patients in whom attempted restoration(2 year)
- The number of interventions required(2 year)