O2 Tension During TAVI

Not Applicable

Completed

• Conditions: Troponin
• Interventions: Other: high inspired oxygen fraction; Other: normal inspired oxygen fraction

• Registration Number: NCT03291210
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-25
• Study Start: 2017-10-18
• Primary Completion: 2022-04-06
• Status Verified: 2022-07
• Study Completion: 2022-07-18
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperoxemia	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.
Normoxemia	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.

Primary Outcome Measures

Name	Time	Method
Troponin I	72 hours after the end of procedure	Area under the curve of troponin I

Secondary Outcome Measures

Name	Time	Method
CK MB	72 hours after the end of procedure	Area under the curve of CK MB
Delirum	through admission completion, an average of 5 days	Newly onset delirium
stroke, myocardial infarction or mortality	through admission completion, an average of 5 days	Newly onset stroke, myocardial infarction or mortality
AKI or RRT	through admission completion, an average of 5 days	Newly onset acute kidney injury or renal replacement therapy
Changes in cerebral oximetry	through procedure completion, an average of 3 hours	changes in cerebral oximetry during the procedure

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of