Intraoperative Hyperoxia and MINS

• Conditions: Myocardial Infarction; Myocardial Injury; Hyperoxia

• Registration Number: NCT04540276
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

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).

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 Timeline

• Study Start: 2018-02-04
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-07
• Primary Completion: 2020-10-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7700

Inclusion Criteria

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

Exclusion Criteria

• Patients with unobtainable data on perioperative FiO2.
• Patients with unobtainable data on postoperative troponin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (8)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

Inkosi Albert Luthuli Hospital; 🇿🇦 Durban, South Africa

Foundation CardioInfanil; 🇨🇴 Bogotá, Colombia

Bispebjerg Hospital; 🇩🇰 Copenhagen, NV, Denmark

Prince of Wales Hospital; 🇨🇳 Hong Kong, China

Walter C. Mackenzie Health Sciences Centre; 🇨🇦 Edmonton, Canada

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Christian Medical College; 🇮🇳 Ludhiāna, India