Risk of Oxygen During Cardiac Surgery Trial
Purpose
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.
Condition
- Cardiac Surgery
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.
Exclusion Criteria
- 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. - Pregnancy
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Normoxia |
Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery. |
|
|
Active Comparator Hyperoxia |
Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery. |
|
More Details
- Status
- Completed
- Sponsor
- Vanderbilt University