OSA as a Remote Ischemic Preconditioning in Vascular Surgery

St. Anne's University Hospital Brno, Czech Republic

Status: Enrolling

Conditions: Ischemia Reperfusion Injury; Vascular Aneurysm; Obstructive Sleep Apnea

Treatments: Procedure: aorto-bifemoral bypass surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04630535

IIT/2019/25

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Obstructive Sleep Apnea

Description:

Pacient with OSA (AHI≥5) undergoing aorto-bifemoral bypass

Treatment:

Procedure: aorto-bifemoral bypass surgery

Without Obstructive Sleep Apnea

Description:

Patinets without OSA undergoing aorto-bifemoral bypass

Treatment:

Procedure: aorto-bifemoral bypass surgery