Skip to main content
OpenTrials
Completed

NCT Number: NCT03291210

O2 Tension 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Troponin

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal inspired oxygen fraction

Other

receives inspired oxygen fraction of 0.3

high inspired oxygen fraction

Other

receives inspired oxygen fraction of 0.8

Primary outcomes

  1. Troponin I

    Time frame: 72 hours after the end of procedure

    Area under the curve of troponin I

Secondary outcomes

  1. CK MB

    Time frame: 72 hours after the end of procedure

    Area under the curve of CK MB

  2. Changes in cerebral oximetry

    Time frame: through procedure completion, an average of 3 hours

    changes in cerebral oximetry during the procedure

  3. Delirum

    Time frame: through admission completion, an average of 5 days

    Newly onset delirium

  4. AKI or RRT

    Time frame: through admission completion, an average of 5 days

    Newly onset acute kidney injury or renal replacement therapy

  5. stroke, myocardial infarction or mortality

    Time frame: through admission completion, an average of 5 days

    Newly onset stroke, myocardial infarction or mortality

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of O2 Tension on Myocardial Injury During TAVI

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2017
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.