O2 Tension During TAVI

Seoul National University

Status: Completed

Conditions: Troponin

Treatments: Other: high inspired oxygen fraction; Other: normal inspired oxygen fraction

Study type: Interventional

Funder types: Other

Identifiers

NCT03291210

TAVI-O2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Normoxemia

Experimental group

Description:

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.

Treatment:

Other: normal inspired oxygen fraction

Hyperoxemia

Active Comparator group

Description:

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.

Treatment:

Other: high inspired oxygen fraction