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Clinical Trials/NCT03939832
NCT03939832WithdrawnNot Applicable

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

Seoul National University Hospital2 sites in 2 countriesStarted: November 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
hospital LOS

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

hospital LOS

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

length of hospital stay after cardiac surgery using cardiopulmonary bypass

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yunseok Jeon

Professor of Anesthesiology and Pain Medicine

Seoul National University Hospital

Study Sites (2)

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