Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- New lesions on control brain magnetic resonance imaging.
研究概览
简要总结
The objective of this study is to investigate the value of employing the aortic no-touch off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary revascularization.
详细描述
Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offset survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue, is off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.
In this randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment and one control arms. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with a partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG. The primary endpoint will be the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective and/or urgent coronary artery bypass
排除标准
- •emergent and salvage setting
- •score below age- and education-adjusted cut-off scores in mini mental state examination
- •score above 8 on the subscales of hospital anxiety and depression scale
- •neurologic deficit of any etiology
- •previous psychiatric illness
- •use of tranquilizers or antipsychotics
- •alcohol or drug abuse
- •history of cardiac surgery
- •left ventricular ejection fraction less than 30%
- •extracranial carotid artery stenosis of more than 70%
- •body mass index of more than 35 kg/m2
- •any contraindication for magnetic resonance imaging (e.g., magnetic resonance imaging - incompatible implantable device and claustrophobia)
结局指标
主要结局
New lesions on control brain magnetic resonance imaging.
时间窗: 3 days after surgery
Appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
次要结局
- New focal neurological deficits.(7 days after surgery)
- Incidence of delirium(7 days after surgery)
- Occurence of postoperative cognitive dysfunction(1 week or 3 months after surgery)
研究者
Krzysztof Szwed
Dr.
Collegium Medicum w Bydgoszczy
