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临床试验/NCT04540276
NCT04540276Unknown不适用

Intraoperative Hyperoxia and MINS: A Post Hoc Analysis From the VISION Study Database

University Hospital Bispebjerg and Frederiksberg8 个研究点 分布在 8 个国家目标入组 7,700 人开始时间: 2018年2月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
7,700
试验地点
8
主要终点
Myocardial injury after non-cardiac surgery (MINS)

研究概览

简要总结

Oxygen therapy is administered to all patients during general anesthesia to maintain tissue oxygenation and prevent hypoxia and ischemia. However, liberal use of oxygen may lead to hyperoxia and some studies suggest that supranormal levels of arterial oxygen saturation may lead to complications. In this post hoc substudy of the VISION cohort, we plan to assess the association between perioperative inspired oxygen fraction (FiO2) and myocardial injury after non-cardiac surgery (MINS).

详细描述

Patients will be divided into five groups of median intraoperative FiO2 (quintiles), in which baseline characteristics and outcomes will be illustrated.

The odds ratio (OR) for the primary and secondary outcomes will be calculated in a logistic regression analysis with median FiO2 (continuous variable) as independent variable.

Analyses are performed with multiple logistic regression with adjustment for the following potentially confounding variables:

Age ≥75 years. Male sex. Current atrial fibrillation. History of diabetes. History of congestive heart failure. History of coronary artery disease. History of recent (i.e., < 6 months) high-risk coronary artery disease. History of stroke. History of peripheral vascular disease. History of hypertension. Preoperative eGFR (<30 vs. 30-44 vs. 45-59 vs. ≥60 mL/min/1.73m2). Low-risk surgery. Duration of surgery.

研究设计

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

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

  • Patients entered in the VISION database, aged 18 years or above, undergoing noncardiac surgery in general anesthesia.

排除标准

  • Patients with unobtainable data on perioperative FiO
  • Patients with unobtainable data on postoperative troponin.

结局指标

主要结局

Myocardial injury after non-cardiac surgery (MINS)

时间窗: Within 30 days after surgery.

Number of participants with MINS in the specified oxygen groups. MINS is defined as either ischemic troponin elevation or myocardial infarction after non-cardiac surgery.

次要结局

  • All-cause mortality(Within 30 days after surgery)
  • Myocardial infarction(Within 30 days after surgery)
  • MINS(Within 30 days after surgery)
  • Rehospitalization for vascular reasons(Within 30 days after surgery)
  • Pneumonia(Within 30 days after surgery)

研究者

发起方
University Hospital Bispebjerg and Frederiksberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sofie Pedersen

MD, PhD-student at Dept. of Anesthesia and Intensive Care

University Hospital Bispebjerg and Frederiksberg

研究点 (8)

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