The Fusion Versus The Affinity Oxygenation Systems - A Prospective Randomized Trial In Patients Undergoing Coronary Artery Bypass Grafting (CABG)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- major adverse events
研究概览
简要总结
This study compares between the clinical, hematological, inflammatory and neurological outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which different oxygenation systems will be used.
详细描述
In order to assess the efficacy and safety of fusion Oxygenation System in patients undergoing isolated CABG, a prospective one-to-one randomized trial comparing the fusion oxygenation to the currently used affinity oxygenation system will be conducted. Forty patients intending to undergo CABG will be divided into 2 groups according to the oxygenation system which will be used during surgery. Distribution into groups will be done randomly. Ten patients undergoing elective peripheral vascular surgical procedures under general anesthesia and 10 patients undergoing elective percutaneous coronary intervention will serve as control groups for the neurological outcomes. Clinical status, inflammatory and hematological response as well as Neurological outcome will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-75 years old) undergoing first-time, isolated CABG at the Hebrew University, Hadassah Medical Center, Jerusalem, Israel and the University Hospital of Angers, Angers, France.
- •Patients undergoing elective peripheral vascular surgical procedures under general anesthesia
- •Patients undergoing elective percutaneous coronary intervention will serve as control groups
排除标准
- •Emergency operations
- •Left ventricular ejection fraction less than 30%
- •CABG with concomitant procedure
- •Previous stroke or documented neurological disorder
- •High grade (>70%) unilateral or bilateral carotid stenosis
- •Contraindication to MRI testing.
研究组 & 干预措施
Fusion oxygenation system
Fusion oxygenation machine will be used during the operation.
干预措施: fusion oxygenation system (Device)
Affinity oxygenation system
Affinity oxygenation machine will be used during the operation.
干预措施: Affinity oxygenation system (Device)
Peripheral vascular procedure
No oxygenation machine will be used in this group
percutaneous coronary intervention
No oxygenation machine will be used in this group
结局指标
主要结局
major adverse events
时间窗: Participants will be followed for 30 days following the surgery
Number of major adverse events (including mortality) will be assessed
次要结局
- Neurological outcomes- electroencephalogram (EEG)(Participants will be followed 3 days following the surgery.)
- Number of participants with abnormal laboratory values(Participants will be followed for 3 days following the surgery.)
- Neurological outcomes-Functional magnetic resonance imaging (MRI)(Changes in brain activity pattern will be assessed at baseline and 4 weeks postoperatively .)
- Neurological outcomes-Transcranial Doppler (TCD)(Participants will be followed 3 days following the surgery.)
- Systemic inflammatory response(Participants will be followed 3 days following the surgery.)
研究者
Oz Shapira
DIRECTOR OF THE DEPARTMENT OF CARDIOTHORACIC SURGERY
Hadassah Medical Organization