O2 Tension During TAVI
Effect of O2 Tension on Myocardial Injury During TAVI
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedStudy Start
First participant enrolled
October 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2022
CompletedJuly 19, 2022
July 1, 2022
4.5 years
September 18, 2017
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Troponin I
Area under the curve of troponin I
72 hours after the end of procedure
Secondary Outcomes (5)
CK MB
72 hours after the end of procedure
Changes in cerebral oximetry
through procedure completion, an average of 3 hours
Delirum
through admission completion, an average of 5 days
AKI or RRT
through admission completion, an average of 5 days
stroke, myocardial infarction or mortality
through admission completion, an average of 5 days
Study Arms (2)
Normoxemia
EXPERIMENTALPatients randomized to the normoxemia group receives inspired oxygen fraction of 0.3 from initiation of induction of anesthesia to the end of the procedure.
Hyperoxemia
ACTIVE COMPARATORPatients randomized to the hyperoxemia group receives inspired oxygen fraction of 0.8 from initiation of induction of anesthesia to the end of the procedure.
Interventions
Eligibility Criteria
You may qualify if:
- Scheduled for transcatheter aortic valve replacement due to aortic stenosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Yunseok Jeon, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal investigator
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 25, 2017
Study Start
October 18, 2017
Primary Completion
April 6, 2022
Study Completion
July 18, 2022
Last Updated
July 19, 2022
Record last verified: 2022-07