Clinical trial NCT04540276: Intraoperative Hyperoxia and MINS
Official title: Intraoperative Hyperoxia and MINS: A Post Hoc Analysis From the VISION Study Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperoxia
Myocardial Infarction
Myocardial Injury
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
First posted: 2020-09-07
Enrollment: 7700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients entered in the VISION database, undergoing noncardiac surgery in general anesthesia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Myocardial injury after non-cardiac surgery (MINS)
timeFrame: Within 30 days after surgery.
Secondary outcomes:
measure: All-cause mortality
timeFrame: Within 30 days after surgery
measure: Myocardial infarction
timeFrame: Within 30 days after surgery
measure: MINS
timeFrame: Within 30 days after surgery
measure: Rehospitalization for vascular reasons
timeFrame: Within 30 days after surgery
measure: Pneumonia
timeFrame: Within 30 days after surgery
Other outcomes:
measure: Vascular mortality
timeFrame: Within 30 days after surgery
measure: Non-fatal cardiac arrest
timeFrame: Within 30 days after surgery
measure: Cardiac revascularization procedure
timeFrame: Within 30 days after surgery
measure: Pulmonary embolism
timeFrame: Within 30 days after surgery
measure: New-onset clinically important atrial fibrillation
timeFrame: Within 30 days after surgery
measure: Peripheral arterial thrombosis
timeFrame: Within 30 days after surgery
measure: Severe sepsis or septic shock
timeFrame: Within 30 days after surgery
measure: Surgical wound infection
timeFrame: Within 30 days after surgery
measure: Deep venous thrombosis
timeFrame: Within 30 days after surgery
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Edmonton
country: Canada
facility: Walter C. Mackenzie Health Sciences Centre
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Bogotá
country: Colombia
facility: Foundation CardioInfanil
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
city: Ludhiāna
country: India
facility: Christian Medical College
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Durban
country: South Africa
facility: Inkosi Albert Luthuli Hospital
Study officials:
affiliation: University hospital Bispebjerg Frederiksberg
name: Christian S. Meyhoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Healt Research Institute
name: PJ Devereaux, MD, PhD
role: STUDY_CHAIR
References: