Intraoperative Hyperoxia and MINS

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Myocardial Injury; Hyperoxia
• Intervention / Treatment: Drug: Inspiratory oxygen fraction

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 Type: Observational
• Enrollment (Anticipated): 7700

Contacts and Locations

Study Locations

• Canada
  • Edmonton, Canada
    • Walter C. Mackenzie Health Sciences Centre
• China
  • Hong Kong, China
    • Prince of Wales Hospital
• Colombia
  • Bogotá, Colombia
    • Foundation CardioInfanil
• Denmark
  • NV
    • Copenhagen, NV, Denmark, 2400
      • Bispebjerg Hospital
• India
  • Ludhiāna, India
    • Christian Medical College
• Malaysia
  • Kuala Lumpur, Malaysia
    • University Malaya Medical Centre
• South Africa
  • Durban, South Africa
    • Inkosi Albert Luthuli Hospital
• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients entered in the VISION database, undergoing noncardiac surgery in general anesthesia.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial injury after non-cardiac surgery (MINS)	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.	Within 30 days after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Number of deaths within 30 days after surgery	Within 30 days after surgery
Myocardial infarction	Number of participants with myocardial infarction within 30 days after surgery	Within 30 days after surgery
MINS	Number of participants with MINS not fulfilling the fourth universal definition of myocardial infarction	Within 30 days after surgery
Rehospitalization for vascular reasons	Number of participants rehospitalized for vascular reasons within 30 days after surgery	Within 30 days after surgery
Pneumonia	Number of participants with pneumonia within 30 days after surgery	Within 30 days after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular mortality	Number of vascular deaths within 30 days after surgery	Within 30 days after surgery
Non-fatal cardiac arrest	Number of participants with non-fatal cardiac arrest within 30 days after surgery	Within 30 days after surgery
Cardiac revascularization procedure	Number of participants undergoing cardiac revascularization procedure within 30 days after surgery	Within 30 days after surgery
Pulmonary embolism	Number of participants with pulmonary embolism within 30 days after surgery	Within 30 days after surgery
New-onset clinically important atrial fibrillation	Number of participants with new-onset clinically important atrial fibrillation within 30 days after surgery	Within 30 days after surgery
Peripheral arterial thrombosis	Number of participants with peripheral arterial thrombosis within 30 days after surgery	Within 30 days after surgery
Severe sepsis or septic shock	Number of participants with severe sepsis or septic shock within 30 days after surgery	Within 30 days after surgery
Surgical wound infection	Number of participants with surgical wound infection defined as surgical incision infection or surgical abscess	Within 30 days after surgery
Deep venous thrombosis	Number of participants with deep venous thrombosis within 30 days after surgery	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): February 4, 2018
• Primary Completion (Actual): October 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Signs and Symptoms, Respiratory; Myocardial Infarction; Infarction; Hyperoxia
• Other Study ID Numbers: Hyperoxia and MINS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No