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O2 Tension During TAVI

NCT03291210 — Not applicable, Completed, 72 participants, Seoul National University Hospital

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Effect of O2 Tension on Myocardial Injury During TAVI

RegistryNCT03291210
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment72 (Actual)
SponsorSeoul National University Hospital (Other)
ConditionsTroponin
Interventionsnormal inspired oxygen fraction, high inspired oxygen fraction (Other)
Datesstart 2017-10-18, primary completion 2022-04-06, completion 2022-07-18, first posted 2017-09-25, last updated 2022-07-19
Locations1 site in South Korea

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
NormoxemiaExperimentalOther: normal inspired oxygen fractionPatients randomized to the normoxemia group receives inspired oxygen fraction of 0.3 from initiation of induction of anesthesia to the end of the procedure.
HyperoxemiaActive comparatorOther: high inspired oxygen fractionPatients randomized to the hyperoxemia group receives inspired oxygen fraction of 0.8 from initiation of induction of anesthesia to the end of the procedure.
  • normal inspired oxygen fraction (Other): receives inspired oxygen fraction of 0.3
  • high inspired oxygen fraction (Other): receives inspired oxygen fraction of 0.8

+Outcome measures

Primary outcomes

  • Troponin I [72 hours after the end of procedure]: Area under the curve of troponin I

Secondary outcomes

  • 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

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Seoul National University HospitalSeoulSouth Korea

+Investigators

My Notes