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临床试验/NCT05263154
NCT05263154招募中不适用

Goal-directed Low vs. High Oxygen Therapy During Anesthesia for Abdominal Surgery

Umeå University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年3月28日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karl A Franklin

Profesor, Consultant surgeon

Umeå University

研究点 (2)

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