Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04540276
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2020-08-31
Brief Title:
Intraoperative Hyperoxia and MINS
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
Intraoperative Hyperoxia and MINS A Post Hoc Analysis From the VISION Study Database
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 mLmin173m2 Low-risk surgery Duration of surgery
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 ie 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 mLmin173m2 Low-risk surgery Duration of surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None