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Recruiting NCT04630535

OSA as a Remote Ischemic Preconditioning in Vascular Surgery

— Observational Obstructive Sleep Apnea Vascular Aneurysm Ischemia Reperfusion Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: aorto-bifemoral bypass surgery.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Vascular Aneurysm, Ischemia Reperfusion Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Change of I/R injury markers [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]
Secondary outcome measures (1)
  • post-operative complications [Time frame: up to 30 post-operative days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Czechia · 1 center
  • St. Anne's University Hospital Brno — Brno

Publications

  • Katseni K, Chalkias A, Kotsis T, Dafnios N, Arapoglou V, Kaparos G, Logothetis E, Iacovidou N, Karvouni E, Katsenis K. The Effect of Perioperative Ischemia and Reperfusion on Multiorgan Dysfunction following Abdominal Aortic Aneurysm Repair. Biomed Res Int. 2015;2015:598980. doi: 10.1155/2015/598980. Epub 2015 Dec 21. PMID 26798637
  • Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124. PMID 3769170
  • Walsh SR, Boyle JR, Tang TY, Sadat U, Cooper DG, Lapsley M, Norden AG, Varty K, Hayes PD, Gaunt ME. Remote ischemic preconditioning for renal and cardiac protection during endovascular aneurysm repair: a randomized controlled trial. J Endovasc Ther. 2009 Dec;16(6):680-9. doi: 10.1583/09-2817.1. PMID 19995115
  • Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18. PMID 20484066
  • Li C, Li YS, Xu M, Wen SH, Yao X, Wu Y, Huang CY, Huang WQ, Liu KX. Limb remote ischemic preconditioning for intestinal and pulmonary protection during elective open infrarenal abdominal aortic aneurysm repair: a randomized controlled trial. Anesthesiology. 2013 Apr;118(4):842-52. doi: 10.1097/ALN.0b013e3182850da5. PMID 23353795
  • Murphy N, Vijayan A, Frohlich S, O'Farrell F, Barry M, Sheehan S, Boylan J, Conlon N. Remote ischemic preconditioning does not affect the incidence of acute kidney injury after elective abdominal aortic aneurysm repair. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1285-92. doi: 10.1053/j.jvca.2014.04.018. PMID 25281045
  • Healy DA, Boyle E, McCartan D, Bourke M, Medani M, Ferguson J, Yagoub H, Bashar K, O'Donnell M, Newell J, Canning C, McMonagle M, Dowdall J, Cross S, O'Daly S, Manning B, Fulton G, Kavanagh EG, Burke P, Grace PA, Moloney MC, Walsh SR; Preconditioning Shields Against Vascular Events in Surgery (Preconditioning SAVES) Trial Group. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Pr PMID 26574485
  • Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916. PMID 27688236

Identifiers

NCT: NCT04630535 · IIT/2019/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗