The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The number of packed red cell units transfused intra-operatively
研究概览
简要总结
In cardiac operations under cardiopulmonary bypass(CPB), monitoring of brain tissue oxygen saturation with infrared spectrophotoscopy leads to a reduction of the number of packed red cell(PRC) transfusions during the period of extracorporeal circulation.
详细描述
The purpose of this study is to investigate whether the use of brain tissue oxygen saturation monitoring will lead to a reduction of the intra-operative use of packed red cell units.
Patients randomly allocated to groups A and B. In group A INVOS monitoring available. In group B, no access to INVOS for the attending anesthesiologist. An "observer" anesthesiologist has access to INVOS and provides information if it is considered necessary.
For BOTH GROUPS:
During CBP and before aortic unclamping, PRC not to be given if hemoglobin is >7g/dl. For values less than 5.5g/dl, one unit of PRC is transfused and the patient is reevaluated. After weaning from CPB and retransfusion of the salvaged shed blood, transfusion when hemoglobin is <8g/dl. During ICU stay, transfusion when hemoglobin is <8g/dl. Between 8-10g/dl evaluation for transfusion in a multimodal manner.
For GROUP A:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac operations under cardiopulmonary bypass, consequently (including coronary-aortic bypass graft), valve replacement, surgery of the ascending aorta, combined procedures, redo-operations)
排除标准
- •Cardiac operations without the aid of extracorporeal circulation (ex. "off-pump" techniques)
- •Emergency operations
研究组 & 干预措施
GROUP A
Brain tissue oxygen saturation monitoring
干预措施: Brain tissue oxygen saturation monitoring (Procedure)
GROUP B
CONTROL GROUP
干预措施: Transfusion according to the anesthesiologist's judgement (Procedure)
结局指标
主要结局
The number of packed red cell units transfused intra-operatively
时间窗: one year
次要结局
- The volume of any kind of intravenous fluids administered to the patient(one year)
- The hematocrit values at certain timeframes(one year)
- The INVOS values electronically and continuously(one year)
- The volume of urine output from the initiation to termination of CPB and to the end(one year)
研究者
STAVROULA GEORGOPOULOU
MD
Larissa University Hospital