Screening for Biomarkers of Cardiovascular and/or Neurological Fragility: A Longitudinal Prospective Cohort Study Based on the Population Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Continuous measurement of alpha band power (in dB).
研究概览
简要总结
More accurate and earlier identification of people at risk of cardiovascular disease (CVD) and neurodegenerative diseases (memory, cognition, dementia) through the appropriate use of biomarkers could lead to earlier initiation of preventive therapies and potentially avoid sometimes fatal events and complications.
Biomarkers are useful for determining the risk of disease, but also for establishing a diagnosis.
High inter-individual variability hinders the establishment of general laws that can be- used in predictive medicine.
In addition to the lack of validation, other limitations are the low participation rate in screening campaigns (regardless of disease) and the relative difficulty, accuracy, cost and time taken to perform the measurements.
The perioperative period is a very good time to screen for cardiovascular and neurodegenerative pathologies for several reasons:
- Patients come to their anesthesia consultation and to the operating room because they have a direct visible benefit.
- the physiological data collected intraoperatively during systematic monitoring are very "rich" and of very good quality because they are not very noisy
- The induction of general anesthesia or the onset of locoregional anesthesia and its maintenance represents a strong and reproducible physiological "test" for the cardiovascular and cerebral systems.
- The patients are regularly re-examined postoperatively for the follow-up of their pathology and the possible complications are recorded in their file, allowing a short and medium term follow-up.
The project aims to validate a biomarker predictive of cardiovascular complications, the pulse wave velocity, and a biomarker predictive of cognitive disorders, the power of the Alpha wave on the electroencephalogram, from the data usually collected during each anesthesia and during the perioperative period. The objective is to build a predictive model of cardiovascular and neurodegenerative risks, possibly combined, on a survival analysis.
详细描述
More accurate and earlier identification of people at risk for cardiovascular disease (CVD) and neurodegenerative diseases (memory, cognition, dementia) through the appropriate use of biomarkers could lead to earlier initiation of preventive therapies and potentially avoid sometimes fatal events and complications.
Biomarkers Biomarkers are useful for determining disease risk, but also for making a diagnosis. Although there is an overabundance of predictive models of CVD and/or neurodegenerative disease risk for the general population, few have been externally validated, so they are currently not widely used by practitioners, policy makers, and designers of public health guidelines. High inter-individual variability hinders the establishment of general laws for use in predictive medicine.
Screening In addition to the lack of validation, other limitations are the low participation rate in screening campaigns (regardless of disease) and the relative difficulty, accuracy, cost, and time taken to perform the measurements.
Why anaesthesia
The perioperative period is a very good time to screen for cardiovascular and neurodegenerative diseases for several reasons:
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 45 years old
- •Eligible for outpatient or scheduled surgery or interventional procedures under general anesthesia or locoregional anesthesia with sedation.
- •Patient having expressed no objection to participation in this research.
- •Patient who is not subject to a legal protection measure
排除标准
- •Patients under 45 years of age.
- •Patient opposed to participation in the protocol
- •Pregnant woman
- •Patient under judicial protection
- •Patient not affiliated to a social health system
结局指标
主要结局
Continuous measurement of alpha band power (in dB).
时间窗: Day 1
For all patients, to authorize a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Assessement of the depth of anesthesia (thanks to Patient State Index (PSI)) by coutinuous frontal EEG recording by Sedline.
时间窗: Day 1
For all patients, To create a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Non-invasive measurement of systolic pulsatility index (SPI in %).
时间窗: 34 days
For all patients, to light on a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Continuous digital photoplethysmography (PPG) recording (SpO2 in %)
时间窗: Day 1
For all patients, to hinge a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
To find a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
时间窗: 5 years
Psychometric testing with the Motor function by the FTT (Finger Taping Test).
Continuous measurement of burst suppression (in percent).
时间窗: Day 1
For all patients, to establish a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Discontinuous measurement of Systolic and Diastolic blood pressure by an oscillometric brachial blood pressure monitor (in mmHg)
时间窗: Day 1
For all patients, to develop a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Continuous electrocardiogram recording
时间窗: Day 1
For all patients, to provide a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
To unearth a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
时间窗: 5 years
Psychometric testing with the MoCA (Montreal Cognitive assessment). The scale is rated out of 30.
To reveal a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
时间窗: 2 days
Research of postoperative delirium by the CAM (Confusion Assessment Method) scale. The diagnosis of delirium requires the presence of 3 of the 4 criteria.
To uncover a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
时间窗: 5 years
Psychometric testing with the Lawton dependency scale with 4 items. The test is rated out of 4.
To establish a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia and at 5 years with the occurrence of fatal and non-fatal cardiovascular complications
时间窗: 5 years
With the measurement of occurrence of fatal (all-cause cardiovascular mortality at 2 years and up to 5 years) and non-fatal cardiovascular complications (myocardial infarction, stroke)
Continuous measurement of 95% spectral frequency front (SEF95) on Sedlin frontal EEG.
时间窗: Day 1
For all patients, to base a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Non-invasive measurement of arterial stiffness by pulse wave velocity (PWV in m/s)
时间窗: 34 days
For all patients, to enact a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Continuous non-invasive measurement of mean arterial pressure (MAP in mmHg)
时间窗: Day 1
For all patients, to found a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Delivered doses of hypnotics, morphine and paralytic agents
时间窗: Day 1
For all patients, to constitute a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
次要结局
- To establish the association between biomarker values and radiological (brain imaging) and biological cardiac biomarkers.(5 years)