In Vivo Optimization Study of the Braindex Cerebral Tissue Oxygen Saturation (SctO2) Measurement Algorithm Compared to a Mixed Reference Value of Jugular Venous and Systemic Arterial Saturation During Proven Cerebral Autoregulation Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Braindex
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Optimization of SctO2 Braindex algorithm
研究概览
简要总结
The objective of this clinical trial is to optimize Braindex brain tissue oxygen saturation (SctO2) measurement algorithm compared to a mixed reference value of jugular venous and systemic arterial saturation, during proven reproducible and standardized loss of brain autoregulation induced during transcatheter aortic valve replacement procedures. The main question it aims to answer is: assessing and improving the sensitivity/specificity of Braindex SctO2 measurements.
Study type: single-center, prospective, interventional, open-label, exploratory clinical trial.
Participant population/health status:
- Patient, male or female, over 18 years of age
- Patient scheduled for percutaneous femoral aortic valve replacement with aortic valve balloon deployment (Edwards Sapien valve) under simple sedation with Remifentanil (TIVA), with spontaneous ventilation.
The expected outcome of this research is to optimize in vivo the algorithm for calculating the SctO2 of the BRAINDEX sensor in surgical conditions, in a context of proven low cerebral flow, on a target population. It is expected, in the long run, a better quality of detection of the loss of cerebral auto-regulation leading to a faster and optimal correction, thus potentially limiting the risk of POCD, subcortical stroke and postoperative cognitive decline.
详细描述
SPONSOR BRAINDEX sas Parc Eurasanté 12 avenue Pierre Mauroy 59120 Loos
INVESTIGATOR COORDINATOR Professor Julien AMOUR Institut de Perfusion, de Réanimation et d'Anesthésie de Chirurgie Cardiaque Paris Sud (IPRA) Hôpital Privé Jacques Cartier 6 avenue du Noyer Lambert 91300 Massy, France
TITLE In vivo optimization study of the algorithm for measuring cerebral tissue oxygen saturation (SctO2) by Braindex compared with a mixed reference value of jugular venous and systemic arterial saturation during proven loss of cerebral auto-regulation.
ID-RCB NUMBER 2022-A02770-43
JUSTIFICATION / BACKGROUND The incidence of postoperative cognitive impairment (POCD) in cardiac surgery is of the order of 30-50%. Loss of cerebral autoregulation is a factor in POCD and cognitive decline. Cerebral near-infrared oximetry (NIRS), a commercially available non-invasive monitoring system, aims to detect and limit the loss of cerebral autoregulation during intraoperative hemodynamic instability.
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 to undergo percutaneous femoral aortic valve replacement with aortic valve deployment by balloon (Edwards Sapien valve) under simple sedation with remifentanil in TIVA, with spontaneous ventilation
- •Patient affiliated or entitled to a social security plan
- •Patient having received written and informed information about the study and having signed a free and free and informed consent to participate in the study.
排除标准
- •Emergency surgery
- •Patient weighing less than 40 kg
- •Patient with a history of ischemic stroke
- •Patient with a contraindication to jugular and arterial catheterization
- •Patient with a contraindication to the Braindex device
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Pregnant, parturient or breastfeeding woman
- •Patient hospitalized without consent
结局指标
主要结局
Optimization of SctO2 Braindex algorithm
时间窗: Duration of the patient's Trans-catheter Aortic Valve Implantation procedure
SctO2 which is Tissular Cerebral Saturation in Oxygène expressed in percentage
次要结局
- Validation of Analgesia Nociception Index (MDoloris) acquired via frontal Braindex frontal PPG(Duration of the patient's Trans-catheter Aortic Valve Implantation procedure)
- Validation of Braindex EEG measures(Duration of the patient's Trans-catheter Aortic Valve Implantation procedure)