Intraoperative Monitoring and Optimisation of Tissue Oxygenation In High-Risk Surgical Patients for Reduction of Postoperative Complications: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- incidence of perioperative complications
研究概览
简要总结
Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk surgical patients may decrease the risk of postoperative complications.
Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The investigators want to see if an algorithm aimed at optimizing intraoperative tissue oxygenation reduces perioperative complications as well as length of stay in the intensive care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Major elective surgery
- •Aged over 65 years with moderate functional limitation of one or more organ systems
- •ASA classification III or IV, i.e. severe cardiac, vascular, respiratory or metabolic illness resulting in severe functional limitation
- •Routine use of arterial and central venous lines
- •Planned postoperative stay on ICU or PACU
排除标准
- •Refusal of consent
- •acute myocardial ischemia prior to enrolment
- •patients receiving palliative treatment only
- •disseminated malignancy
- •patients unlikely to survive more than 6 hours
- •emergency surgery
- •transplantations
- •neurosurgical patients
- •patients undergoing extensive liver surgery requiring low CVP management
研究组 & 干预措施
standard care
The data from the InSPectra Monitor in the Control group will be inaccessible for the Investigator since this is not a part of their daily medical practice
Treatment group,
The data given by the monitor will be available for the Investigator and used to apply the optimization protocol
干预措施: connected to the InSpectra Monitor (Device)
结局指标
主要结局
incidence of perioperative complications
时间窗: during operation
organ dysfunction, SOFA score, troponin T, creatinin, CRP
次要结局
未报告次要终点
研究者
Prof.dr.T.W.L.Scheeren
Prof.dr.
University Medical Center Groningen