About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass

Clinicaltrials.gov identifier NCT03939832

Recruitment Status Withdrawn (Due to COVID-19 pandemic, it was no possible to recruit patients for this study.)

First Posted May 7, 2019

Last update posted March 29, 2021

Study Description

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.

  • Condition or Disease:Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass
  • Intervention/Treatment: Other: Fraction of inspired oxygen level
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Other
  • Official Title: Effect of Intraoperative Oxygen Tension on Patient Outcomes After Cardiac Surgery With Cardiopulmonary Bypass: a Pilot Study
  • Estimated Study Start Date: November 2021
  • Estimated Primary Completion Date: November 2022
  • Estimated Study Completion Date: December 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: FiO2 0.5
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.
Active Comparator: FiO2 1.0
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts
Locations

Korea, Republic of
Seoul National University Hospital
Seoul

Sponsors and Collaborators

Seoul National University Hospital

More Information
  • Responsible Party: Seoul National University Hospital
  • ClinicalTrials.gov Identifier: NCT03939832 History of Changes
  • Other Study ID Numbers: FiO2 CPB
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: March 29, 2021
  • Last Verified: March 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No