Pilot Prospective Randomized Clinical Trial "Insufflation of Carbon Dioxide During Minimally Invasive and Repeated Cardiac Surgery"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- delirium: CAM-ICU, 3-D CAM
研究概览
简要总结
study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive
详细描述
prospective randomized clinical single-center study of the efficacy and safety of using carbon dioxide in deaeration of cardiac cavities during cardiac surgery (repeated interventions and minimally invasive interventions)
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned cardiac surgery on the left heart with limited deaeration: Minimally invasive approach (mininotomy, minimally invasive lateral thoracotomy); Re-intervention
- •Signed informed voluntary consent
排除标准
- •Patient refusal to participate in any stage of the study
- •History of stroke, transient ischemic attack
- •Hemodynamically significant stenosis of the brachiocephalic arteries (more than 70%)
- •Swelling or thrombosis of the heart
- •LV dysfunction (EF less than 30%)
- •Atherosclerosis of the aorta (atheromatosis)
- •Surgical access conversion
研究组 & 干预措施
carbon dioxide insufflation
patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery + standard methods of deaeration of cardiac cavities
干预措施: carbon dioxide insufflation (Procedure)
no carbon dioxide
standard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle
干预措施: No carbon dioxide insufflation (Procedure)
结局指标
主要结局
delirium: CAM-ICU, 3-D CAM
时间窗: 7 days after surgery
positive test development of postoperative delirium: Richmond Agitation-Sedation Scale, Confusion Assessment Method-Intensive Care Unit (more than one error) - while in the intensive care unit; positive test the 3-Minute Diagnostic Interview for Confusion Assessment Method (CAM) defined delirium - while in the ward of the department: The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness.
次要结局
- neurocognitive dysfunction(7 days after surgery)
- deaeration time(intraoperatively)