OSA as a Remote Ischemic Preconditioning in Vascular Surgery

Last updated: April 16, 2024
Sponsor: St. Anne's University Hospital Brno, Czech Republic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Aneurysm

Occlusions

Treatment

aorto-bifemoral bypass surgery

Clinical Study ID

NCT04630535
IIT/2019/25
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndromepatients)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: aorto-bifemoral bypass surgery
Phase:
Study Start date:
November 01, 2020
Estimated Completion Date:
January 31, 2026

Study 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

Connect with a study center

  • St. Anne's University Hospital Brno

    Brno, Czech Republic 65691
    Czechia

    Active - Recruiting

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