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OSA as a Remote Ischemic Preconditioning in Vascular Surgery

Obstructive Sleep Apnea as a Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04630535
Enrollment
100
Registered
2020-11-16
Start date
2020-11-01
Completion date
2029-01-31
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia Reperfusion Injury, Obstructive Sleep Apnea, Vascular Aneurysm

Keywords

remote preconditioning

Brief summary

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.

Detailed description

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

Interventions

PROCEDUREaorto-bifemoral bypass surgery

aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)

Sponsors

St. Anne's University Hospital Brno, Czech Republic
Lead SponsorOTHER
Masaryk University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)

Exclusion criteria

* emergent surgery * aorto-bifemoral bypass using deep vein graft * re-operations * known OSA with CPAP treatment

Design outcomes

Primary

MeasureTime frameDescription
Change of I/R injury markersT0 - 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 dayPlasma Total Antioxidant Capacity and Reactive Oxygen Species Concentration

Secondary

MeasureTime frameDescription
post-operative complicationsup to 30 post-operative dayscardiovascular and pulmonary post-operative complications

Countries

Czechia

Contacts

CONTACTIvan Cundrle, M.D., Ph.D.
ivan.cundrle@fnusa.cz00420543182553
CONTACTMarek Lukes, M.D.
marek.lukes@fnusa.cz00420543182553
PRINCIPAL_INVESTIGATORIvan Cundrle, M.D., Ph.D.

St. Anne's University Hospital in Brno

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026