Intraoperative Hyperoxia and MINS
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Myocardial injury after non-cardiac surgery (MINS) [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.
Secondary Outcome Measures
- All-cause mortality [Within 30 days after surgery]
Number of deaths within 30 days after surgery
- Myocardial infarction [Within 30 days after surgery]
Number of participants with myocardial infarction within 30 days after surgery
- MINS [Within 30 days after surgery]
Number of participants with MINS not fulfilling the fourth universal definition of myocardial infarction
- Rehospitalization for vascular reasons [Within 30 days after surgery]
Number of participants rehospitalized for vascular reasons within 30 days after surgery
- Pneumonia [Within 30 days after surgery]
Number of participants with pneumonia within 30 days after surgery
Other Outcome Measures
- Vascular mortality [Within 30 days after surgery]
Number of vascular deaths within 30 days after surgery
- Non-fatal cardiac arrest [Within 30 days after surgery]
Number of participants with non-fatal cardiac arrest within 30 days after surgery
- Cardiac revascularization procedure [Within 30 days after surgery]
Number of participants undergoing cardiac revascularization procedure within 30 days after surgery
- Pulmonary embolism [Within 30 days after surgery]
Number of participants with pulmonary embolism within 30 days after surgery
- New-onset clinically important atrial fibrillation [Within 30 days after surgery]
Number of participants with new-onset clinically important atrial fibrillation within 30 days after surgery
- Peripheral arterial thrombosis [Within 30 days after surgery]
Number of participants with peripheral arterial thrombosis within 30 days after surgery
- Severe sepsis or septic shock [Within 30 days after surgery]
Number of participants with severe sepsis or septic shock within 30 days after surgery
- Surgical wound infection [Within 30 days after surgery]
Number of participants with surgical wound infection defined as surgical incision infection or surgical abscess
- Deep venous thrombosis [Within 30 days after surgery]
Number of participants with deep venous thrombosis within 30 days after surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients entered in the VISION database, aged 18 years or above, undergoing noncardiac surgery in general anesthesia.
Exclusion Criteria:
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Patients with unobtainable data on perioperative FiO2.
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Patients with unobtainable data on postoperative troponin.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 2 | Walter C. Mackenzie Health Sciences Centre | Edmonton | Canada | ||
| 3 | Prince of Wales Hospital | Hong Kong | China | ||
| 4 | Foundation CardioInfanil | Bogotá | Colombia | ||
| 5 | Bispebjerg Hospital | Copenhagen | NV | Denmark | 2400 |
| 6 | Christian Medical College | Ludhiāna | India | ||
| 7 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | ||
| 8 | Inkosi Albert Luthuli Hospital | Durban | South Africa |
Sponsors and Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Population Health Research Institute
Investigators
- Principal Investigator: Christian S. Meyhoff, MD, PhD, University hospital Bispebjerg Frederiksberg
- Study Chair: PJ Devereaux, MD, PhD, Population Healt Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Hyperoxia and MINS