Patients Undergoing Cardiac Surgery Using Cardiopulmonary BypassNCT03939832
FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass
A study testing Fraction of inspired oxygen level in people with Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass, run by Seoul National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass
- What is being tested?
- Fraction of inspired oxygen level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for cardiac surgery using cardiopulmonary bypass
Who cannot join
- Planned implementation of deep hypothermic circulatory arrest
- Preoperative respiratory support with the fraction of inspired oxygen of 0.5 and more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Oxygen Tension on Patient Outcomes After Cardiac Surgery With Cardiopulmonary Bypass: a Pilot Study
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.
- Being tested
- Fraction of inspired oxygen level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| FiO2 0.5 | Active comparator | Not described Receives: Other: Fraction of inspired oxygen level |
| FiO2 1.0 | Active comparator | Not described Receives: Other: Fraction of inspired oxygen level |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital LOS
length of hospital stay after cardiac surgery using cardiopulmonary bypass
Measured: From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Due to COVID-19 pandemic, it was no possible to recruit patients for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Cardiac Surgery Using Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939832
- Sponsor's protocol ID
- FiO2 CPB
- Status last verified
- Mar 2021
- First submitted
- 3 May 2019
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Oxygen Tension on Patient Outcomes After Cardiac Surgery With Cardiopulmonary Bypass: a Pilot Study
- ClinicalTrials.gov ID
- NCT03939832
- Acronym / sponsor ID
- FiO2 CPB
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 pandemic, it was no possible to recruit patients for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FiO2 0.5 | Active comparator | Other: Fraction of inspired oxygen level |
| FiO2 1.0 | Active comparator | Other: Fraction of inspired oxygen level |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled for cardiac surgery using cardiopulmonary bypass
Key exclusion criteria (2 listed)
- Planned implementation of deep hypothermic circulatory arrest
- Preoperative respiratory support with the fraction of inspired oxygen of 0.5 and more.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fraction of inspired oxygen levelA fraction of inspired oxygen level during cardiac surgery using cardiopulmonary bypass will be set differently: 0.5 versus 1.0. | Other | FiO2 0.5, FiO2 1.0 |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
Related trials for Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass
Not yet recruitingPhase 3
Transfusion Reduction in High-Bleeding-Risk Cardiac Surgery With Desmopressin
Adult Patients Undergoing Cardiac Surgery, High Bleeding Risks
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fraction of inspired oxygen level in people with Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital LOS (time frame: From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.