CSINVOS: Non-invasive Measurement of Regional Intracerebral Tissue Oxygenation in Elective Cardiac Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) Questionnaire
研究概览
简要总结
Patients after cardiac surgical operations often exhibit neuropsychological complications. In particular, the post-operative delirium is associated with a significantly increased morbidity and mortality.
Intracerebral microembolization in addition to inadequate cerebral perfusion during surgery was verified as the main cause of this.
The aim of the study is to demonstrate a correlation between intraoperative low measured cerebral oxygen levels and a loss neurological outcome, especially the development of postoperative delirium, using non-invasive cerebral oximetry (RSO2).
详细描述
Before the operation, the parameters required for the collection of the EURO-scores are recorded, allowing an assessment of perioperative risk (age, gender, type of planned surgery, concomitant diseases).
After the patient arrives in the operating room the required electrodes to measure the intracerebral oxygenation are stuck bitemporal on the patient´s head. The measurement of oxygenation begins before induction of anaesthesia (while the patient is still awake) and will continue until 24 h postoperatively.
The measurement of cerebral oxygenation is not intended to serve as a replacement for the collection of routine peripheral oxygen saturation, but will be performed additionally.Therefore the anaesthesiological management depends primarily on the peripheral oxygen saturation and arterial blood gases according to our clinical routine.
If, however, intracerebral oxygenation shows an ominous decline, this change can be corrected by targeted measures very early (such as increasing the inspiratory oxygen concentration). At the specified test points following additional parameters are determined: Mean arterial blood pressure, central venous blood pressure, cardiac output, serum lactate, venous oxygen saturation, arterial blood gas analysis, fluid balance. These parameters are collected as part of a routine cardiac surgery. To measure these parameters no additional punctuation or blood draws are therefore necessary. To determine the cytokines IL-6 and IL-10, procalcitonin (PCT) and the S-100 protein, however, it is necessary to take 5ml blood to the respective measuring points from an already existing venous access.
In the ICU the collection of the above mentioned parameters occurs at admission, after 6h and 12h, and on the morning of the first postoperative day (and possibly on further ICU-treatment-days). Additionally, each 12 h after surgery, the SOFA and the CAM-ICU-Score are recorded.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Age of 18 years or older
- •Elective cardiac surgery at heart-lung-machine
排除标准
- •Pregnancy or lactation period
- •Patients not capable of consenting
- •Emergency surgery
- •Patients under 18 years
- •Known depression
结局指标
主要结局
CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) Questionnaire
时间窗: Changes between 6 - 48 hours before surgery and 12 hours after surgery
CAM-ICU Quesionnaire is used to assess the patient´s ability of postoperative orientation, to detect and treat changes between preoperative and postoperative questionnaires and therefore a potential postoperative delirium earliest possible.
次要结局
- S-100 Protein(Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.)
- MIF (Macrophage Migration Inhibitory Factor)(Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.)
- Cytokine IL-10(Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.)
- Procalcitonin (PCT)(Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.)
- Cytokine IL-6(Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.)
- SOFA-Score (Sequential Organ Failure Assessment score)(12 hours after surgery)