Coronary Artery DiseaseNCT03945565
FiO2 and Outcomes After OPCAB (the CARROT Trial)
A study testing Fraction of inspired oxygen level in people with Coronary Artery Disease, 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 including off-pump coronary artery bypass grafting (OPCAB). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Fraction of inspired oxygen level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to 12 Sep 2021
- 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 elective off-pump coronary artery bypass grafting
Who cannot join
- emergency
- robot-assisted surgery
- minimally invasive cardiac surgery requiring thoracotomy/one-lung anesthesia
- preoperative pulmonary morbidity requiring oxygen therapy
- preoperative use of ECMO or IABP
- preoperative tracheal intubation or mechanical ventilation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Seoul, 03080
About this study
Official title: Effect of Intraoperative Oxygen Tension on Patient Outcomes After Off-pump Coronary Artery Bypass Grafting (the CARROT Trial)
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 including off-pump coronary artery bypass grafting (OPCAB). 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 has not been reached among practitioners yet. This study is a multicenter study (Seoul National University, Asan Medical Center, Severance Hospital) where the effect of different level of FiO2 on postoperative clinical outcomes is evaluated.
Read the detailed description
A sub-study will also be conducted in part of patients of the present study. In 40 out of 500 (expected) patients, two different levels of FiO2 will be sequentially set with a 5-minute interval after the induction of general anesthesia. Mixed venous and regional cerebral oxygen saturation will then be recorded according to the change of FiO2.
- Conditions
- Coronary Artery Disease
- Being tested
- Fraction of inspired oxygen level
- Medical subject headings
- Coronary Artery Disease
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 off-pump coronary artery bypass grafting will be set differently between the study groups: 0.3 vs 0.8.
| Study group | Role | What they receive |
|---|---|---|
| FiO2 0.3 | Active comparator | Patients allocated to this group are going to receiving FiO2 of 0.3 during surgery Receives: Other: Fraction of inspired oxygen level |
| FiO2 0.8 | Active comparator | Patients allocated to this group are going to receiving FiO2 of 0.8 during surgery 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 off-pump coronary artery bypass grafting
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 posted10 May 2019
- Study start1 Aug 2019
- Primary completion17 Aug 2021
- Study completion12 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Severance Hospital
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945565
- Sponsor's protocol ID
- FiO2 OPCAB
- Status last verified
- Feb 2022
- First submitted
- 8 Apr 2019
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nam K, Nam JS, Kim HB, Chung J, Hwang IE, Ju JW, Bae J, Lee S, Cho YJ, Shim JK, Kwak YL, Chin JH, Choi IC; CARdiac suRgery and Oxygen Therapy (CARROT) Investigators; Lee EH, Jeon Y. Effects of intraoperative inspired oxygen fraction (FiO2 0.3 vs 0.8) on patients undergoing off-pump coronary artery bypass grafting: the CARROT multicenter, cluster-randomized trial. Crit Care. 2023 Jul 13;27(1):286. doi: 10.1186/s13054-023-04558-8.
PubMed 37443130
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Oxygen Tension on Patient Outcomes After Off-pump Coronary Artery Bypass Grafting (the CARROT Trial)
- ClinicalTrials.gov ID
- NCT03945565
- Acronym / sponsor ID
- FiO2 OPCAB
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Severance Hospital
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 10 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 including off-pump coronary artery bypass grafting (OPCAB). 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 has not been reached among practitioners yet. This study is a multicenter study (Seoul National University, Asan Medical Center, Severance Hospital) where the effect of different level of FiO2 on postoperative clinical outcomes is evaluated.
Detailed description
A sub-study will also be conducted in part of patients of the present study. In 40 out of 500 (expected) patients, two different levels of FiO2 will be sequentially set with a 5-minute interval after the induction of general anesthesia. Mixed venous and regional cerebral oxygen saturation will then be recorded according to the change of FiO2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FiO2 0.3 | Active comparator | Other: Fraction of inspired oxygen levelPatients allocated to this group are going to receiving FiO2 of 0.3 during surgery |
| FiO2 0.8 | Active comparator | Other: Fraction of inspired oxygen levelPatients allocated to this group are going to receiving FiO2 of 0.8 during surgery |
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 elective off-pump coronary artery bypass grafting
Key exclusion criteria (6 listed)
- emergency
- robot-assisted surgery
- minimally invasive cardiac surgery requiring thoracotomy/one-lung anesthesia
- preoperative pulmonary morbidity requiring oxygen therapy
- preoperative use of ECMO or IABP
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 off-pump coronary artery bypass grafting will be set differently between the study groups: 0.3 vs 0.8. | Other | FiO2 0.3, FiO2 0.8 |
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 off-pump coronary artery bypass grafting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 37443130Nam K, Nam JS, Kim HB, Chung J, Hwang IE, Ju JW, Bae J, Lee S, Cho YJ, Shim JK, Kwak YL, Chin JH, Choi IC; CARdiac suRgery and Oxygen Therapy (CARROT) Investigators; Lee EH, Jeon Y. Effects of intraoperative inspired oxygen fraction (FiO2 0.3 vs 0.8) on patients undergoing off-pump coronary artery bypass grafting: the CARROT multicenter, cluster-randomized trial. Crit Care. 2023 Jul 13;27(1):286. doi: 10.1186/s13054-023-04558-8.
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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.
Yunseok Jeon principal investigator
Seoul National University Hospital
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 Coronary Artery Disease, 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 6 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: finished, as of the sponsor's last update on 9 Feb 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT03945565, which also lists 1 linked publication.
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 9 Feb 2022.