Intraoperative Hyperoxia and MINS

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04540276
• Other study ID #: Hyperoxia and MINS
• Status: Active, not recruiting
• Start date: February 4, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2021
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7700
• Est. completion date: March 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperoxia
• Infarction
• Myocardial Infarction
• Myocardial Injury

Intervention

Drug:
• Inspiratory oxygen fraction
Median inspiratory oxygen fraction during general anesthesia

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Population Health Research Institute

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vascular mortality	Number of vascular deaths within 30 days after surgery	Within 30 days after surgery
Other	Non-fatal cardiac arrest	Number of participants with non-fatal cardiac arrest within 30 days after surgery	Within 30 days after surgery
Other	Cardiac revascularization procedure	Number of participants undergoing cardiac revascularization procedure within 30 days after surgery	Within 30 days after surgery
Other	Pulmonary embolism	Number of participants with pulmonary embolism within 30 days after surgery	Within 30 days after surgery
Other	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
Other	Peripheral arterial thrombosis	Number of participants with peripheral arterial thrombosis within 30 days after surgery	Within 30 days after surgery
Other	Severe sepsis or septic shock	Number of participants with severe sepsis or septic shock within 30 days after surgery	Within 30 days after surgery
Other	Surgical wound infection	Number of participants with surgical wound infection defined as surgical incision infection or surgical abscess	Within 30 days after surgery
Other	Deep venous thrombosis	Number of participants with deep venous thrombosis within 30 days after surgery	Within 30 days after surgery
Primary	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	All-cause mortality	Number of deaths within 30 days after surgery	Within 30 days after surgery
Secondary	Myocardial infarction	Number of participants with myocardial infarction within 30 days after surgery	Within 30 days after surgery
Secondary	MINS	Number of participants with MINS not fulfilling the fourth universal definition of myocardial infarction	Within 30 days after surgery
Secondary	Rehospitalization for vascular reasons	Number of participants rehospitalized for vascular reasons within 30 days after surgery	Within 30 days after surgery
Secondary	Pneumonia	Number of participants with pneumonia within 30 days after surgery	Within 30 days after surgery