NCT03939832

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
2.5 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

May 3, 2019

Last Update Submit

March 24, 2021

Conditions

Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

FiO2 0.5

ACTIVE COMPARATOR
Other: Fraction of inspired oxygen level

FiO2 1.0

ACTIVE COMPARATOR
Other: Fraction of inspired oxygen level

Interventions

Fraction of inspired oxygen levelOTHER

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

FiO2 0.5FiO2 1.0

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients scheduled for cardiac surgery using cardiopulmonary bypass

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology and Pain Medicine

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 7, 2019

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations

KR(1)