An observational study in Obstructive Sleep Apnea, Vascular Aneurysm and Ischemia Reperfusion Injury, sponsored by St. Anne's University Hospital Brno, Czech Republic. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by St. Anne's University Hospital Brno, Czech Republic · Observational
Ischemia and reperfusion (I/R) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia.
Studies of ischemic preconditioning in patients with AAA are conflicting. Obstructive sleep apnea (OSA) is a sleep disordered breathing syndrome which may have a protective effect against ischemia.
The investigators hypothesize that I/R injury will be less pronounced in patients who have OSA and that the extent of I/R injury will inversely correlate with OSA severity. Accordingly, the aim of this study is to compare postoperative complications and markers of I/R in patients undergoing elective AAA repair who do and do not have OSA.
Patients. Consecutive patients scheduled for elective aortobifemoral bypass (AAA and Leriche syndrome patients) will be recruited for this prospective, observational study.
Polygraphy (PG). PG measurements will be done two nights before surgery using the Embletta system (Embla - Embletta MPR PG Sleep Data Recording System).
STOP-BANG, Epworth questionnaire. Both questionnaires will be done the same day as polygraphy
Cardiovascular complications will be assessed from the first 30 post-operative days Pulmonary complications will be assessed from the first 30 post-operative days
Specific markers of I/R. T0 - before anesthesia induction T1 - 3 hrs after aorta de-clamping T2 - 12 hrs after aorta de-clamping T3 - 24 hrs after aorta de-clamping T4 - on the fifth post-operative day
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 100 is close to the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →St. Anne's University Hospital Brno, Czech Republic is the lead sponsor of 25 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
consecutive patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pacient with OSA (AHI≥5) undergoing aorto-bifemoral bypass
Procedure: aorto-bifemoral bypass surgery
Patinets without OSA undergoing aorto-bifemoral bypass
Procedure: aorto-bifemoral bypass surgery
aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)
Change of I/R injury markers
Plasma Total Antioxidant Capacity and Reactive Oxygen Species Concentration
Time frame: T0 - before anesthesia induction; T1 - 3 hrs after aorta de-clamping; T2 - 12 hrs after aorta de-clamping; T3 - 24 hrs after aorta de-clamping; T4 - on the fifth post-operative day
post-operative complications
cardiovascular and pulmonary post-operative complications
Time frame: up to 30 post-operative days
Plan to share: No
Started Nov 2020 (actual). Primary completion is estimated for Dec 2028, 97 months after the start.
Of 258 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's planned 97 months is above that.
Counting every sponsor, half of 294 studies reached it within 28 months; a quarter within 14 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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St. Anne's University Hospital Brno, Czech Republic