Goal-directed Low vs. High Oxygen Therapy During Anesthesia for Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Mean change in arterial oxygen partial pressure after surgery vs. before surgery
研究概览
简要总结
The study aims at investigate whether low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery. 200 patients scheduled for abdominal surgery will be randomized (1:1) to goal directed low oxygen concentration during and after anesthesia vs. fixed high oxygen concentration. Arterial oxygen partial pressure is the primary outcome and lung function a secondary explanatory outcome.
详细描述
Postoperative hypoxia is a most common complication after major abdominal surgery. This study aims at investigate whether goal-directed low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery.
200 adult patients scheduled for major abdominal cancer surgery lasting for more than 2 hours will be included after signed informed consent. Patients will then be randomized to either goal directed low oxygen or high oxygen during anesthesia and in the postoperative period.
Patients who are randomized to goal directed low oxygen will be given oxygen before the induction of anesthesia, with increasing fraction of inspired oxygen (FiO2) from 0.25 to 0.30 to 0.35 and so on. After intubation, the FiO2 is set to 0.25 to achieve a target saturation of 94-96%. Supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary, Patients who are randomized to high oxygen will be given FiO2 of 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. The FiO2 will be reduced to 0.35 during anesthesia, followed by an increase in FiO2 to 0.80 during 5 minutes before extubating the patient, followed by FiO2 0.40 for at least thirty minutes after anesthesia. Oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98%.
Arterial blood gases, lung function measurements including diffusion capacity will be taken on the day before surgery. Blood gases will be taken during the first and second day after surgery and lung function tests during the second day after surgery. Blood gases and lung function will also be obtained at three months after surgery.
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
- •Being scheduled for a major abdominal cancer surgery lasting for more than 2 hours.
- •Having a condition within American Society of Anesthesia Class 1-3.
排除标准
- •Being at risk for a difficult intubation during anesthesia in the form of Mallampati score 3-4, or having a previous documentation of difficult intubation.
- •Decline participation
结局指标
主要结局
Mean change in arterial oxygen partial pressure after surgery vs. before surgery
时间窗: 3 days
Oxygen partial pressure
次要结局
- Mean change in vital capacity after surgery vs. before surgery(3 months)
- Mean change in forced expiratory volume in one second after surgery vs. before surgery(3 months)
- Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery(3 months)
- Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery(3 months)
- Mean change in arterial oxygen partial pressure after surgery vs. before surgery(3 months)
研究者
Karl A Franklin
Profesor, Consultant surgeon
Umeå University
