FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass

Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03939832
• Other study ID #: FiO2 CPB
• Status: Withdrawn
• Phase: N/A
• Start date: November 2021
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass

Intervention

Other:
• Fraction 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital LOS	length of hospital stay after cardiac surgery using cardiopulmonary bypass	From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks