FiO2 and Outcomes After Cardiac Surgery With Cardiopulmon... | NCT03939832

Studies
FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass

NCT03939832

Sponsor

Seoul National University Hospital

Status

Withdrawn

Last Update Posted

Mar 29, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass

Interventions

Fraction of inspired oxygen level

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to COVID-19 pandemic, it was no possible to recruit patients for this study.

Expanded Access Info

Start Date

Nov 2021Estimated

Primary Completion Date

Nov 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

May 3, 2019

First Submission Date that Met QC Criteria

May 3, 2019

First Posted Date

May 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2021

Last Update Posted Date

Mar 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yunseok Jeon, Professor of Anesthesiology and Pain Medicine, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FiO2 0.5	Active Comparator		Other: Fraction of inspired oxygen level
FiO2 1.0	Active Comparator		Other: Fraction of inspired oxygen level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fraction of inspired oxygen level	Other	A fraction of inspired oxygen level during cardiac surgery using cardiopulmonary bypass will be set differently: 0.5 versus 1.0.	FiO2 0.5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea