Effect of O2 Tension on Myocardial Injury During TAVI
| Registry | NCT03291210 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 72 (Actual) |
| Sponsor | Seoul National University Hospital (Other) |
| Conditions | Troponin |
| Interventions | normal inspired oxygen fraction, high inspired oxygen fraction (Other) |
| Dates | start 2017-10-18, primary completion 2022-04-06, completion 2022-07-18, first posted 2017-09-25, last updated 2022-07-19 |
| Locations | 1 site in South Korea |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Normoxemia | Experimental | Other: normal inspired oxygen fraction | 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. |
| Hyperoxemia | Active comparator | Other: high inspired oxygen fraction | 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. |
Sex: All, ages: 20 Years to 99 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |