Risk of Oxygen During Cardiac Surgery Trial
The investigators will recruit and randomize 200 elective cardiac surgery patients to receive physiologic oxygenation (normoxia) or hyper-oxygenation (hyperoxia) during surgery to test the hypothesis that intraoperative physiologic oxygenation decreases the generation of reactive oxygen species, oxidative damage, and postoperative organ injury compared to hyper-oxygenation.
- Cardiac Surgery
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.
- Current acute coronary syndrome (defined as ST elevation myocardial infarction or non-ST elevation myocardial infarction (troponin leak within 72 hours of surgery or consent +/- EKG changes consistent with myocardial ischemia)).
- Home supplemental oxygen use.
- Preoperative supplemental oxygen requirement to maintain arterial O2 sat of 92%.
- Right to left intracardiac shunt including atrial septal defect and ventricular septal defect with Cor Pulmonale.
- Carotid stenosis defined as >50% stenosis.
- Cardiac surgery that requires intraoperative circulatory arrest, such as aortic arch replacement.
- Current use of hemo- or peritoneal dialysis.
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Outcomes Assessor)
|Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery.||
|Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery.||
- NCT ID
- Vanderbilt University