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临床试验/NCT02399878
NCT02399878Unknown不适用

Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

Massachusetts General Hospital0 个研究点目标入组 70,000 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
70,000
主要终点
Postoperative respiratory complications

研究概览

简要总结

Respiratory complications represent the second most frequent type of postoperative complications with an incidence estimated to range from 2.0% to 7.9%

It has been shown that intra-operative protective ventilation is associated with a reduced risk of respiratory complications. The effects of intra-operative inspiratory oxygen fraction (FiO2) remain to be investigated.

In this study, the investigators aim to investigate the association between intra-operative FiO2 and respiratory complication as well as surgical site infection and ICU admission in patients undergoing non-cardiothoracic surgery. The investigators primary hypothesis is that high intra-operative FiO2 increases the risk of postoperative respiratory complications independent of predefined risk factors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Non-cardiothoracic surgery at Massachusetts General Hospital between January 2007 and August 2015
  • Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure
  • above18 years of age

排除标准

  • Missing information regarding main characteristics or the exposure variable

研究组 & 干预措施

Patients undergoing surgery

All non-cardiothoracic surgical patients aged 18 years or above receiving general anesthesia at Massachusetts General Hospital between January 2007 and August 2014.

干预措施: Inspiratory oxygen (Drug)

结局指标

主要结局

Postoperative respiratory complications

时间窗: 7 days after surgery

次要结局

  • Postoperative pulmonary edema(7 days after surgery)
  • Postoperative surgical site infection(21 days after surgery)
  • Postoperative mortality(30 days after surgery)
  • Postoperative pneumonia(7 days after surgery)
  • Postoperative admission to the intensive care unit(7 days after surgery)
  • Postoperative respiratory failure(7 days after surgery)
  • Postoperative length of stay(360 days after surgery)
  • Postoperative reintubation(7 days after surgery)

研究者

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

Matthias Eikermann

MD, PhD, Associate Professor

Massachusetts General Hospital

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