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WithdrawnNCT03939832Updated Mar 29, 2021

FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass

An interventional study of Fraction of inspired oxygen level in Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass, sponsored by Seoul National University Hospital. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-03-29.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other

Why this study was withdrawn
Due to COVID-19 pandemic, it was no possible to recruit patients for this study.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery using CPB has not been reached among practitioners yet.

02

Conditions studied

  • Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients scheduled for cardiac surgery using cardiopulmonary bypass

Exclusion criteria

Exclusion Criteria:

  • Planned implementation of deep hypothermic circulatory arrest
  • Preoperative respiratory support with the fraction of inspired oxygen of 0.5 and more.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    FiO2 0.5

    Other: Fraction of inspired oxygen level

  • Active comparator
    FiO2 1.0

    Other: Fraction of inspired oxygen level

Interventions

  • OtherFraction of inspired oxygen level

    A fraction of inspired oxygen level during cardiac surgery using cardiopulmonary bypass will be set differently: 0.5 versus 1.0.

06

What researchers measure

Primary outcomes

  1. hospital LOS

    length of hospital stay after cardiac surgery using cardiopulmonary bypass

    Time frame: From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03939832
Lead sponsor
Seoul National University Hospital
Responsible party
Yunseok Jeon (Professor of Anesthesiology and Pain Medicine, Seoul National University Hospital) — Principal investigator
First posted
May 7, 2019
Start date
Nov 2021 (estimated)
Primary completion
Nov 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Mar 29, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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