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FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass

Effect of Intraoperative Oxygen Tension on Patient Outcomes After Cardiac Surgery With Cardiopulmonary Bypass: a Pilot Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03939832
Enrollment
0
Registered
2019-05-07
Start date
2021-11-30
Completion date
2022-12-31
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass

Brief 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.

Interventions

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients scheduled for cardiac surgery using cardiopulmonary bypass

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
hospital LOSFrom the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weekslength of hospital stay after cardiac surgery using cardiopulmonary bypass

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026