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Intraoperative Hyperoxia and MINS

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04540276
Enrollment
7700
Registered
2020-09-07
Start date
2018-02-04
Completion date
2021-03-01
Last updated
2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperoxia, Myocardial Infarction, Myocardial Injury

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.

Interventions

DRUGInspiratory oxygen fraction

Median inspiratory oxygen fraction during general anesthesia

Sponsors

Population Health Research Institute
CollaboratorOTHER
University Hospital Bispebjerg and Frederiksberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
All-cause mortalityWithin 30 days after surgeryNumber of deaths within 30 days after surgery
Myocardial infarctionWithin 30 days after surgeryNumber of participants with myocardial infarction within 30 days after surgery
MINSWithin 30 days after surgeryNumber of participants with MINS not fulfilling the fourth universal definition of myocardial infarction
Rehospitalization for vascular reasonsWithin 30 days after surgeryNumber of participants rehospitalized for vascular reasons within 30 days after surgery
PneumoniaWithin 30 days after surgeryNumber of participants with pneumonia within 30 days after surgery

Other

MeasureTime frameDescription
Peripheral arterial thrombosisWithin 30 days after surgeryNumber of participants with peripheral arterial thrombosis within 30 days after surgery
Severe sepsis or septic shockWithin 30 days after surgeryNumber of participants with severe sepsis or septic shock within 30 days after surgery
Surgical wound infectionWithin 30 days after surgeryNumber of participants with surgical wound infection defined as surgical incision infection or surgical abscess
Deep venous thrombosisWithin 30 days after surgeryNumber of participants with deep venous thrombosis within 30 days after surgery
Vascular mortalityWithin 30 days after surgeryNumber of vascular deaths within 30 days after surgery
Non-fatal cardiac arrestWithin 30 days after surgeryNumber of participants with non-fatal cardiac arrest within 30 days after surgery
Cardiac revascularization procedureWithin 30 days after surgeryNumber of participants undergoing cardiac revascularization procedure within 30 days after surgery
Pulmonary embolismWithin 30 days after surgeryNumber of participants with pulmonary embolism within 30 days after surgery
New-onset clinically important atrial fibrillationWithin 30 days after surgeryNumber of participants with new-onset clinically important atrial fibrillation within 30 days after surgery

Countries

Canada, China, Colombia, Denmark, India, Malaysia, South Africa, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026