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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Severance Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FiO2 0.3 | Active Comparator | Patients allocated to this group are going to receiving FiO2 of 0.3 during surgery |
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| FiO2 0.8 | Active Comparator | Patients allocated to this group are going to receiving FiO2 of 0.8 during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fraction of inspired oxygen level | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| hospital LOS | length of hospital stay after off-pump coronary artery bypass grafting | From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunseok Jeon | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37443130 | Derived | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |