Non-invasive Assessment of Fluid Requirement During Surgery: a Comparison of Oesophageal Doppler and Pleth Variability Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Difference between fluid volumes administered in the intra-operative period
研究概览
简要总结
Targeting the amount of fluid given to measurements of the patients own fluid status during major abdominal surgery has been linked with improved speed of recovery of gut function and reduced length of hospital stay, mortality and complications.
Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more invasive forms of monitoring to direct how much fluid to give.
The study aims primarily to measure and compare how much fluid is given when guided by PVI compared to the established technique; oesophageal doppler during major abdominal surgery.
The study will compare 40 patients undergoing major elective abdominal surgery. Patients will receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the study will examine biochemical markers, length of hospital stay and how frequently complications occur
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Major abdominal surgery
- •Anaerobic Threshold >11 ml O2/kg/min
- •VE/VCO2 <34 OR
- •Low risk according to Consultant anaesthetist
排除标准
- •Patients age less than 18
- •Patient refused consent
- •Patient unable to give consent
- •Patient has had <24hrs to consider the Patient information Sheet
- •Contraindication to Doppler Probe being inserted
- •Emergency Procedure
- •Patient has a ASA Grade 5
- •Patient is receiving dialysis treatment
- •Patient has a known hypersensitivity to hydroxyethyl starch or gelatin solutions
- •Patients with renal failure with oliguria or anuria - not related to hypovolaemia
- •Patients with a previously diagnosed dysrhythmia
- •Patients who weight >100kg
结局指标
主要结局
Difference between fluid volumes administered in the intra-operative period
时间窗: End of operation
次要结局
- Difference in 24 hour fluid balance(24 hours)
- Post-operative morbiditiy survey(7 days)
- Biochemical Markers of Tissue Perfusion(24 hours)