Obstructive sleep apnea (OSA) postoperative risk stratification trial
- Conditions
- G47.3Sleep apnoea
- Registration Number
- DRKS00000704
- Lead Sponsor
- Center for Sepsis Control and Care (CSCC), University Hospital Jena
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 219
Inclusion Criteria
Consecutive patients undergoing elective coronary artery bypass graft surgery.
Exclusion Criteria
•Global respiratory failure
•Heart failure (NYHA III-IV)
•Acute myocardial infarction
•Immune suppression for any reason (for example AIDS,leukaemia, chemotherapy)
•Alcoholic disease
•Progressive cancer disease
•Renal failure requiring dialysis
•Pretreated OSA (CPAP-therapy)
•Hepatic failure (Child-Pugh C)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite end point of postoperative cardiac (reanimation, cardiogenic shock, myocardial ischemia, implantation of a permanent pacemaker), respiratory (acute respiratory failure, reintubation, tracheostomy, prolonged mechanical ventilation >24 hours), neurological (stroke), surgical (reoperation), renal (acute renal failure requiring dialysis), infectious (sepsis, deep wound infection, pneumonia) complications, occurring within 7 days or death within 30 days after coronary artery bypass graft surgery in relation to preexisting OSA.
- Secondary Outcome Measures
Name Time Method •Hospital length of stay (days)<br>•Length of postoperative stay on ICU (hours)<br>•ICU transferral (events)<br>•Postoperative cardiac complications and interventions<br>•Postoperative respiratory complications and interventions<br>•Postoperative neurological complications<br>•Postoperative surgical complications and interventions<br>• Postoperative acute renal failure, requiring dialysis<br>• Postoperative infectious complications<br>•Postoperative SIRS, Sepsis and septic shock <br>•Length of postoperative mechanical ventilation<br>•Reanimation<br>•Mortality at discharge from hospital and within 30 days after surgery<br>•Predispositional factors for infectious complications in OSA such as autonomic, endothelial dysfunction, proinflammatory state and hypercoagulability<br>