Obstructive Sleep Apnea as a Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of I/R injury markers
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)
排除标准
- •emergent surgery
- •aorto-bifemoral bypass using deep vein graft
- •re-operations
- •known OSA with CPAP treatment
研究组 & 干预措施
Without Obstructive Sleep Apnea
Patinets without OSA undergoing aorto-bifemoral bypass
干预措施: aorto-bifemoral bypass surgery (Procedure)
Obstructive Sleep Apnea
Pacient with OSA (AHI≥5) undergoing aorto-bifemoral bypass
干预措施: aorto-bifemoral bypass surgery (Procedure)
结局指标
主要结局
Change of I/R injury markers
时间窗: 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
次要结局
- post-operative complications(up to 30 post-operative days)
研究者
Ivan Cundrle
Principal Investigator
St. Anne's University Hospital Brno, Czech Republic