Coronary Artery Disease Clinical Trial
Official title:
Effect of Intraoperative Oxygen Tension on Patient Outcomes After Off-pump Coronary Artery Bypass Grafting (the CARROT Trial)
Verified date | February 2022 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 414 |
Est. completion date | September 12, 2021 |
Est. primary completion date | August 17, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - All patients scheduled for elective off-pump coronary artery bypass grafting Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anesthesiology and Pain Medicine, Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Asan Medical Center, Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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