NCT06492746招募中不适用
Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To determine the magnitude and duration of CAI
研究概览
简要总结
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥ 45 years
- •Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
- •Planned monitoring with ForeSight sensor and HemoSphere monitor
- •Planned arterial catheterization for blood pressure monitoring
- •High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure > 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease
排除标准
- •Non-English speaking
- •Confirmed to be pregnant
- •Surgery for congenital heart defect
- •Non-availability of HemoSphere with laptop CAI interface
研究组 & 干预措施
Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring
Experimental
干预措施: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring (Device)
结局指标
主要结局
To determine the magnitude and duration of CAI
时间窗: Duration of the procedure through 30 days
To determine the sum of the product of magnitude and duration that CAI during cardiopulmonary bypass (CPB) is at or above the threshold of 45 during current standard of care and assess the incidence of CAI ≥45 in the absence of decreased cerebral StO2 or MAP thresholds.
次要结局
未报告次要终点
研究者
研究点 (2)
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