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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03291210
Other study ID # TAVI-O2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 18, 2017
Est. completion date July 18, 2022

Study information

Verified date July 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date July 18, 2022
Est. primary completion date April 6, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
normal inspired oxygen fraction
receives inspired oxygen fraction of 0.3
high inspired oxygen fraction
receives inspired oxygen fraction of 0.8

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Troponin I Area under the curve of troponin I 72 hours after the end of procedure
Secondary CK MB Area under the curve of CK MB 72 hours after the end of procedure
Secondary Changes in cerebral oximetry changes in cerebral oximetry during the procedure through procedure completion, an average of 3 hours
Secondary Delirum Newly onset delirium through admission completion, an average of 5 days
Secondary AKI or RRT Newly onset acute kidney injury or renal replacement therapy through admission completion, an average of 5 days
Secondary stroke, myocardial infarction or mortality Newly onset stroke, myocardial infarction or mortality through admission completion, an average of 5 days
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