Troponin
Conditions
Keywords
hyperoxemia, myocardial injury, transcatheter aortic valve replacement
Brief summary
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
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.
Interventions
OTHERnormal inspired oxygen fraction
receives inspired oxygen fraction of 0.3
OTHERhigh inspired oxygen fraction
receives inspired oxygen fraction of 0.8
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Troponin I | 72 hours after the end of procedure | Area under the curve of troponin I |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CK MB | 72 hours after the end of procedure | Area under the curve of CK MB |
| Changes in cerebral oximetry | through procedure completion, an average of 3 hours | changes in cerebral oximetry during the procedure |
| Delirum | through admission completion, an average of 5 days | Newly onset delirium |
| AKI or RRT | through admission completion, an average of 5 days | Newly onset acute kidney injury or renal replacement therapy |
| stroke, myocardial infarction or mortality | through admission completion, an average of 5 days | Newly onset stroke, myocardial infarction or mortality |
Countries
South Korea
Outcome results
None listed