O2 Tension During TAVI

Study Overview
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Brief Summary
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Hyperoxemia can produce various complications including oxidative stress and myocardial injury. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after transcatheter aortic valve replacement.

Detailed Description
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Hyperoxemia can produce various complications, such as excessive oxidative stress, hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant myocardial injury. Previous studies have been observed higher mortality in patient group maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after TAVR.

Official Title
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Effect of O2 Tension on Myocardial Injury During TAVI

Conditions
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Troponin

Intervention / Treatment
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* Other: normal inspired oxygen fraction
* Other: high inspired oxygen fraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for transcatheter aortic valve replacement due to aortic stenosis Exclusion Criteria: Transapical approach Pre-procedural PaO2 < 65 mmHg or oxygen support therapy Pre-procedural severe kidney injury (end-stage renal disease) Pre-procedural chronic pulmonary disease, symptomatic asthma Pre-procedural Tb-destroyed lung Lung cancer History of acute coronary syndrome within 6 months Pre-procedural elevated Troponin I or CKMB History of stroke or transient ischemic attack within 6 months Refuse to participate Pregnant

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normoxemia<br>Patients randomized to the normoxemia group receives inspired oxygen fraction of 0.3 from initiation of induction of anesthesia to the end of the procedure. | Other: normal inspired oxygen fraction<br>* receives inspired oxygen fraction of 0.3<br>|
| Active Comparator: Hyperoxemia<br>Patients randomized to the hyperoxemia group receives inspired oxygen fraction of 0.8 from initiation of induction of anesthesia to the end of the procedure. | Other: high inspired oxygen fraction<br>* receives inspired oxygen fraction of 0.8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin I | Area under the curve of troponin I | 72 hours after the end of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CK MB | Area under the curve of CK MB | 72 hours after the end of procedure | 
| Changes in cerebral oximetry | changes in cerebral oximetry during the procedure | through procedure completion, an average of 3 hours | 
| Delirum | Newly onset delirium | through admission completion, an average of 5 days | 
| AKI or RRT | Newly onset acute kidney injury or renal replacement therapy | through admission completion, an average of 5 days | 
| stroke, myocardial infarction or mortality | Newly onset stroke, myocardial infarction or mortality | through admission completion, an average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperoxemia, myocardial injury, transcatheter aortic valve replacement