NCT04540276

Intraoperative Hyperoxia and MINS

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 7,700 (estimated)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Hyperoxia
• Myocardial Infarction
• Myocardial Injury

Interventions

Type	Name	Description
DRUG	Inspiratory oxygen fraction	Median inspiratory oxygen fraction during general anesthesia

Timeline

• Start date: 2018-02-04
• Primary completion: 2020-10-01
• Completion: 2021-03-01
• First posted: 2020-09-07
• Last updated: 2021-02-04

Locations

8 sites across 8 countries: United States, Canada, China, Colombia, Denmark, India, Malaysia, South Africa