Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 330
- Locations
- 2
- Primary Endpoint
- Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
Study Overview
Brief Summary
The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Major patient ≥ 18 years
- •Patient operated cardiac surgery for myocardial revascularization (CABG) or surgical correction of valvular or combined surgery (CABG and valve disease) or ascending aortic surgery
- •Signed Consent
- •Affiliation to social security
Exclusion Criteria
- •Permanent atrial fibrillation
- •Cordarone therapy,
- •Pregnant woman
- •Patient under guardianship or trusteeship or private public law
- •Internal pacemaker
- •Hypothermia,
- •Patient refusal,
- •Cardiac surgery without extracorporal circulation (ECC),
- •Participation in another study.
Arms & Interventions
normoxia
During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.
Intervention: medical oxygen (Drug)
hyperoxia
During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.
Intervention: medical oxygen (Drug)
Outcomes
Primary Outcomes
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
Time Frame: 15 days after surgery
Secondary Outcomes
No secondary outcomes reported