Evaluation of Impacts of Continuous Non-Invasive Intra-Operative Hemoglobin and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 主要终点
- Average Volume of Allogenic RBC Transfused Intra-operatively
研究概览
简要总结
The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring using pulse-oximetry based technologies and their effect on the management of transfusion and infusion decisions and clinical outcomes for the surgical patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Adult patients undergoing major surgeries associated with possibility of significant blood loss (e.g. such that blood is cross-matched and available before the start of the case as per hospital routine practice) under general anesthesia.
- •At least one finger available and accessible for performing non-invasive hemoglobin monitoring.
排除标准
- •Patient has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors
- •Procedures performed using robotics surgery
- •Any patients with a known hemoglobinopathy
- •Any patients undergoing Cardio-Pulmonary Bypass (CPB)
- •Any patients who cannot be transfused or has refused consent for a blood transfusion
- •Patients being treated by any artificial oxygen carriers within 30 days of hospital stay
- •Patients being managed outside of an operating room in the participating centers, or in operating room with conditions not conducive to perform and complete the study procedures (including use of the hemoglobin monitoring device)
- •Patients younger than 18 years old
- •Patients who are pregnant
- •Patients with cardiac arrhythmia
- •Patients with tidal volume setting < 6ml/kg
- •Patients with PEEP >= 10cm H2O
- •Patients undergoing cardiac and/or any open chest procedures
- •Emergency patients due to the foreseeable difficulty in consenting
- •Patients deemed not suitable for study at the discretion of the Principal Investigator
研究组 & 干预措施
Control Group
Clinicians will be performing blood transfusions using hospital standard of care procedures.
Evaluation Group
Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.
干预措施: In vivo SpHb and PVi Monitoring (Device)
结局指标
主要结局
Average Volume of Allogenic RBC Transfused Intra-operatively
时间窗: Approximately 6-8 hours
Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.
次要结局
未报告次要终点