Observational Study on the Clinical Impact of Systemic and Cerebral Desaturation During Liver Transplantation and Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events
研究概览
简要总结
The purpose of this study is to determine the clinical impact of cerebral and systemic desaturation during liver transplantation and resection on post-operative complications.
详细描述
This is an observational study. Cerebral and systemic oxymetry (rSO2) using near infrared spectroscopy (NIRS, Invos 5100; Somanet- ics Corporation, Troy, MI) will be performed on all patients with 4 optodes (right and left temporal area, arm and leg). Continuous rSO2 values will be stored on a hard disk with a 15 seconds update within intraoperative period and first 4 hours after the surgery. Desaturation phases (saturation decrease more than 20% of the basal value for more than 15 seconds) will be correlated to operative procedure or events. Postoperative adverse events will be collected. A correlation between desaturation and postoperative adverse events will be done with a multiple linear regression model.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing an hepatic resection or hepatic transplantation
- •patients able to give consent with knowledge of french or english language.
排除标准
- •age< 18 years
- •patients with cerebral diseases
结局指标
主要结局
define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events
时间窗: from the beginning of anesthesia till 4 hours after the end of the surgery
次要结局
- define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantation(from the beginning of anesthesia till 4 hours after the end of the surgery)
- define the correlation coefficient between systemic and/or cerebral desaturation phases and the length of stay in intensive care unit(duration of intensive care stay, an expected average of 4 days)
- validate the equivalence of the systemic and cerebral oxymetry(from the beginning of anesthesia till 4 hours after the end of the surgery)