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临床试验/NCT04211246
NCT04211246已完成不适用

Efficacy of Oxygen Reserve Index (ORI) to Reduce Hyperoxia in Major Abdominal Surgery

Eunah Cho, MD2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Pressure of arterial oxygen (PaO2) after 1 hour of surgery.

研究概览

简要总结

Excessive oxygen administration is known to cause oxidative stress, and absorption atelectasis. Hyperoxia is very common in general anesthesia settings. Even though there are concerns in using excessive oxygen during general anesthesia, the optimal fraction of inspired oxygen (FiO2) for general anesthesia is not well studied.

The oxygen reserve index (ORI) is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORI that it might be helpful to reduce hyperoxia in critically ill patients in the intensive care unit, as well as in general anesthesia.

The aim of this study is to evaluate efficacy of oxygen reserve index to reduce hyperoxemia in major abdominal surgery.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective major abdominal surgery expected to last more than 2hours.
  • Patients who are scheduled for invasive arterial cannulation during surgery.

排除标准

  • Abnormal pulmonary function test
  • Pregnancy
  • Saturation of oxygen (SpO2) is below 92% in room air

结局指标

主要结局

Pressure of arterial oxygen (PaO2) after 1 hour of surgery.

时间窗: After 1 hour of surgery

Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.

次要结局

  • Pressure of arterial oxygen (PaO2) after 3 hours of surgery.(After 3 hours of surgery)
  • Pressure of arterial oxygen (PaO2) after 2 hours of surgery.(After 2 hours of surgery)
  • Minimal and maximal value of PaO2 throughout the surgery(1 hour after the end of surgery)
  • Oxygen reserve index (ORI)(1 hour after the end of surgery)
  • Fraction of inspired oxygen (FiO2)(1 hour after the end of surgery)

研究者

发起方
Eunah Cho, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eunah Cho, MD

Clinical Assistant Professor

Kangbuk Samsung Hospital

研究点 (2)

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