NCT Number: NCT04630535
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Brno, Czech Republic, 65691, Czechia
Location status: Recruiting
Ivan Cundrle, M.D., Ph.D.
CONTACT
Ivan Cundrle, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Ludmila Tusinovska, M.D.
SUB_INVESTIGATOR
Lukas Ruzek, M.D.
SUB_INVESTIGATOR
Marek Lukes, M.D.
CONTACT
Marek Lukes, M.D.
SUB_INVESTIGATOR
Ondrej Ludka, MD., Ph.D.
SUB_INVESTIGATOR
Tomas Novotny, M.D., Ph.D.
SUB_INVESTIGATOR
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)
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
Plasma Total Antioxidant Capacity and Reactive Oxygen Species Concentration
Time frame: up to 30 post-operative days
cardiovascular and pulmonary post-operative complications
Contact information is provided by the study sponsor or research team.
Ivan Cundrle, M.D., Ph.D.
CONTACT
Marek Lukes, M.D.
CONTACT
St. Anne's University Hospital Brno, Czech Republic
Other
Obstructive Sleep Apnea as a Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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