OSA as a Remote Ischemic Preconditioning in Vascular Surgery

April 16, 2024 updated by: Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Czech Republic
      • Brno, Czech Republic, Czechia, 65691
        • Recruiting
        • St. Anne's University Hospital Brno
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ivan Cundrle, M.D., Ph.D.
        • Sub-Investigator:
          • Lukas Ruzek, M.D.
        • Sub-Investigator:
          • Marek Lukes, M.D.
        • Sub-Investigator:
          • Ondrej Ludka, MD., Ph.D.
        • Sub-Investigator:
          • Tomas Novotny, M.D., Ph.D.
        • Sub-Investigator:
          • Ludmila Tusinovska, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obstructive Sleep Apnea
Pacient with OSA (AHI≥5) undergoing aorto-bifemoral bypass
Procedure: aorto-bifemoral bypass surgery
aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)
Without Obstructive Sleep Apnea
Patinets without OSA undergoing aorto-bifemoral bypass
Procedure: aorto-bifemoral bypass surgery
aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Plasma Total Antioxidant Capacity and Reactive Oxygen Species Concentration
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

Outcome Measure
Measure Description
Time Frame
post-operative complications
Time Frame: up to 30 post-operative days
cardiovascular and pulmonary post-operative complications
up to 30 post-operative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anne's University Hospital Brno, Czech Republic

Collaborators

Masaryk University

Investigators

  • Principal Investigator: Ivan Cundrle, M.D., Ph.D., St. Anne's University Hospital in Brno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT/2019/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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