Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Braindex
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison of SctO2 values from ARGOS and INVOS
研究概览
简要总结
The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values (comparative study with platform INVOS, Medtronic).
详细描述
SctO2 values from ARGOS and INVOS will be resampled every 30 seconds. The two signals will then be resynchronized and compared on a sample-by-sample basis using a Pearson correlation test. Bias and agreement limits will be assessed using Bland & Altmann graphs. This test will be carried out for the entire duration of the recording.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, over 18 years of age
- •Patient scheduled for cardiac surgery with programmed extracorporeal circulation (ECC)
- •Patient with no history of scalp injury or or skin diseases
- •Patient with an Euroscore 2 of less than 7%.
- •Patient affiliated or entitled to a social assurance
排除标准
- •Weight under 40 kg
- •Frontal surface too small to allow application of SctO2, BIS electrodes on the same hemifront
- •Patient with severe, unbalanced hypertension
- •Measurement of systolic blood pressure (SBP) > 180 mm Hg and/or diastolic blood pressure (DBP) > 110 mm Hg
- •Patients undergoing emergency surgery
- •Patient with chronic renal failure, with glomerular filtration < 30 ml/min/1.73m², or requiring renal transplantation or requiring renal transplantation
- •Patient with left ventricular ejection fraction < 40%
- •Patient with a history of ischemic stroke
- •Patients with preoperative sepsis
- •Patient requiring noradrenaline infusion noradrenaline infusion in the 24 hours prior to surgery
- •Patient with preoperative uni or bilateral carotid stenosis bilateral carotid stenosis > 50%.
- •Protected patient: adult under guardianship, curatorship or legal protection, deprived of liberty by judicial or administrative decision.
- •Pregnant, parturient or breast-feeding women.
- •Patients hospitalized without consent.
结局指标
主要结局
Comparison of SctO2 values from ARGOS and INVOS
时间窗: During the surgical procedure
Compare ARGOS and INVOS SctO2 values at different times of interest during the procedure. Compare ARGOS SctO2 values with invasive central venous and arterial saturation (measured by gasometry) during aortic unclamping. Compare INVOS SctO2 values with central venous and arterial saturation before, during and after aortic unclamping.
次要结局
- ANI and Database(During the surgical procedure)