跳至主要内容
临床试验/NCT03939832
NCT03939832撤回不适用

Effect of Intraoperative Oxygen Tension on Patient Outcomes After Cardiac Surgery With Cardiopulmonary Bypass: a Pilot Study

Seoul National University Hospital1 个研究点 分布在 1 个国家开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
hospital LOS

研究概览

简要总结

Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery using CPB has not been reached among practitioners yet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients scheduled for cardiac surgery using cardiopulmonary bypass

排除标准

  • •Planned implementation of deep hypothermic circulatory arrest
  • •Preoperative respiratory support with the fraction of inspired oxygen of 0.5 and more.

研究组 & 干预措施

FiO2 1.0

Active Comparator

干预措施: Fraction of inspired oxygen level (Other)

FiO2 0.5

Active Comparator

干预措施: Fraction of inspired oxygen level (Other)

结局指标

主要结局

hospital LOS

时间窗: From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks

length of hospital stay after cardiac surgery using cardiopulmonary bypass

次要结局

未报告次要终点

研究者

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

Yunseok Jeon

Professor of Anesthesiology and Pain Medicine

Seoul National University Hospital

研究点 (1)

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