Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04630535
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2020-11-04
Brief Title:
OSA as a Remote Ischemic Preconditioning in Vascular Surgery
Sponsor:
St Annes University Hospital Brno Czech Republic
Organization:
St Annes University Hospital Brno Czech Republic
Study Overview
Official Title:
Obstructive Sleep Apnea as a Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ischemia and reperfusion IR 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 IR injury will be less pronounced in patients who have OSA and that the extent of IR injury will inversely correlate with OSA severity Accordingly the aim of this study is to compare postoperative complications and markers of IR in patients undergoing elective AAA repair who do and do not have OSA
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 IR injury will be less pronounced in patients who have OSA and that the extent of IR injury will inversely correlate with OSA severity Accordingly the aim of this study is to compare postoperative complications and markers of IR 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 IR 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
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 IR 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None