OSA as a Remote Ischemic Preconditioning in Vascular Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Anne's University Hospital Brno, Czech Republic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)
Disqualifiers
emergent surgery
aorto-bifemoral bypass using deep vein graft
re-operations
known OSA with CPAP treatment
Trial population
consecutive patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
aorto-bifemoral bypass surgery
Procedure/Surgeryaorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Obstructive Sleep Apnea1 intervention
Group B: Without Obstructive Sleep Apnea1 intervention
Trial outcomes
Primary outcomes
1
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 daySecondary outcomes
1
post-operative complications
cardiovascular and pulmonary post-operative complications
Time frame
up to 30 post-operative daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Anne's University Hospital Brno, Czech Republic
Lead sponsor
Masaryk University
Collaborator
Source ClinicalTrials.gov