O2 Tension During TAVI

Effect of O2 Tension on Myocardial Injury During TAVI

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.

Study Overview

• Status: Completed
• Conditions: Troponin
• Intervention / Treatment: Other: normal inspired oxygen fraction; Other: high inspired oxygen fraction

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Normoxemia; 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.	Other: normal inspired oxygen fraction; receives inspired oxygen fraction of 0.3
ACTIVE_COMPARATOR: Hyperoxemia; 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.	Other: high inspired oxygen fraction; receives inspired oxygen fraction of 0.8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Troponin I	Area under the curve of troponin I	72 hours after the end of procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2017
• Primary Completion (ACTUAL): April 6, 2022
• Study Completion (ACTUAL): July 18, 2022

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (ACTUAL): September 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: myocardial injury; transcatheter aortic valve replacement; hyperoxemia
• Other Study ID Numbers: TAVI-O2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No