FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass

Not Applicable

Withdrawn

• Conditions: Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass
• Interventions: Other: Fraction of inspired oxygen level

• Registration Number: NCT03939832
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-29
• Study Start: 2021-11
• Primary Completion: 2022-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FiO2 0.5	Fraction of inspired oxygen level	-
FiO2 1.0	Fraction of inspired oxygen level	-

Primary Outcome Measures

Name	Time	Method
hospital LOS	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of