Evaluation of the Continuous Measurement of Tissular (StO2) and Cerebral (ScO2) Oxygenation During Lung Surgery and During the 6 First Postoperative Hours (Prospective Monocentric Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Desaturation during surgery and early postoperative recovery whatever the device.
研究概览
简要总结
The purpose of this study is to compare the ability of two peripheral and non invasive devices to detect hypoxic events during one-lung ventilation and during the early postoperative period. One device measures regional cerebral oxygenation and the other muscular oxygenation. These two devices are compared to non invasive arterial saturation (SpO2), which is the gold standard.
详细描述
Lung surgery is often complicated by hypoxic evants :
- during one-lung ventilation which leads to changes about ratio in ventilated and perfused lung areas. This blood flow redistribution promotes shunt with a decreased arterial oxygenation and possible hypoxemia.
- during the postoperative period.
Common measure of arterial saturation through SpO2 may miss a great number of hypoxic events with regional impact because a significant decrease in SpO2 occurs for an arterial pressure in oxygen below 60 mmHg. Currently, cerebral and somatic saturation can be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and to the thenar eminence. These devices may help clinicians in the detection of such hypoxemic events.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled lung surgery requiring one-lung ventilation
- •informed consent
排除标准
- •Pregnant woman
- •Neurologic or psychiatric disorders
结局指标
主要结局
Desaturation during surgery and early postoperative recovery whatever the device.
时间窗: 6 hours postoperative
Number of episodes
次要结局
- Quality of signal(6 hours postoperative)
- Chronology between devices in case of desaturation(6 hours post operative)