Advantages of Pulse Pressure Variation (PPV) Monitoring in Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- PaO2/FiO2 ratio
研究概览
简要总结
Peri-operative fluid-therapy is extremely important in thoracic surgery, because excessive administration of fluids during one-lung ventilation is correlated to an increasing risk of postoperative respiratory complications.
Therefore, current guidelines on peri-operative management of patients undergoing thoracic surgery suggest a conservative fluid management strategy, based on intra-operative fluid loss replacement and maintenance of euvolemia.
Nevertheless, intra-operative fluid loss estimation and consequently the correct infusion rate adoption are quite difficult to be addressed in clinical practice, and this often prevents the euvolemia maintenance in the peri-operative period.
This limit claims the necessity to adopt new methods of fluid-therapy administration in thoracic surgery; among these the most promising is the "Goal-Directed Therapy" (GDT). GDT protocols based on Stroke Volume Variation (SVV) or Pulse Pressure Variation (PPV) monitoring have been adopted successfully in major and cardiac surgery but not yet in thoracic surgery.
The aim of this randomized study is to evaluate the effects of a PPV-GDT fluid management protocol versus a conservative "zero-balance" protocol on intrapulmonary gas exchanges, in patients undergoing single-lung ventilation during thoracic surgery.
详细描述
The intra-operative fluid-therapy (using lactated Ringer) will be based on pulse pressure variation (PPV group) with a target ≤5.8% or on compensation (1:1) of urine output (zero balance group).
In both groups an intraoperative background infusion of lactated Ringer at 1-2 ml/kg/h will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult patients scheduled for Video-assisted thoracic surgery (VATS) lobectomy
排除标准
- •Patients who will not sign the informed consent
- •Obesity (BMI > 35 kg/m2)
- •Cardiovascular disease (heart failure, arrhythmia)
- •OSAS requiring or not C-PAP therapy
- •Chronic alcoholism
- •intraoperative blod loss> 1500 ml
- •One-lung ventilation duration< 60 min
结局指标
主要结局
PaO2/FiO2 ratio
时间窗: 15 minutes after extubation
Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fraction of inspired oxygen (FiO2)
次要结局
- In-hospital stay(Days until discharge, an average of 5 days)
- Postoperative pulmonary complications(Up to 3 days after surgery)