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O2 Tension During TAVI

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03291210
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
57
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: normal inspired oxygen fraction
  • Other: high inspired oxygen fraction
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of O2 Tension on Myocardial Injury During TAVI
Actual Study Start Date :
Oct 18, 2017
Actual Primary Completion Date :
Apr 6, 2022
Actual Study Completion Date :
Jul 18, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Troponin I [72 hours after the end of procedure]

    Area under the curve of troponin I

Secondary Outcome Measures

  1. CK MB [72 hours after the end of procedure]

    Area under the curve of CK MB

  2. Changes in cerebral oximetry [through procedure completion, an average of 3 hours]

    changes in cerebral oximetry during the procedure

  3. Delirum [through admission completion, an average of 5 days]

    Newly onset delirium

  4. AKI or RRT [through admission completion, an average of 5 days]

    Newly onset acute kidney injury or renal replacement therapy

  5. stroke, myocardial infarction or mortality [through admission completion, an average of 5 days]

    Newly onset stroke, myocardial infarction or mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Yunseok Jeon, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yunseok Jeon, Prinicipal investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT03291210
Other Study ID Numbers:
  • TAVI-O2
First Posted:
Sep 25, 2017
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yunseok Jeon, Prinicipal investigator, Seoul National University Hospital
hyperoxemia
myocardial injury
transcatheter aortic valve replacement

Study Results

No Results Posted as of Jul 19, 2022