Precision Assessment of Perioperative Effectiveness and Safety of Transthoracic Minimally Invasive Hybrid Closure for Pediatric Ventricular Septal Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Respiratory dysfunction as measured by PaO2
研究概览
简要总结
Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations. In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure for pediatric VSD in the clinical practice, precision assessment of perioperative its effectiveness and safety has already become an important issue that must be solved. On the basis of echocardiography, integrating with characteristics associated critical care, the investigators focus on precision assessment of perioperative effectiveness and safety of transthoracic hybrid closure for pediatric VSD, compared with conventional surgical sternotomy repair with cardiopulmonary bypass (CPB).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of perimembranous ventricular septal defect, muscular ventricular septal defect, doubly committed subarterial VSD by transesophageal echocardiogram (TEE) with VSD size 5-12mm;
- •no significant aortic insufficiency or aortic valve prolapse.
排除标准
- •confirmed pulmonary hypertension (systolic pulmonary arterial pressure >75mmHg or pulmonary vascular resistance >8.0 Wood U/m2);
- •more than mild degree of aortic regurgitation and obvious aortic valve prolapse;
- •preoperative congestive heart failure;
- •other coexisting cardiac anomalies;
- •infective endocarditis.
研究组 & 干预措施
Off-pump hybrid closure
Hybrid closure is that a periventricular technique uses an occluding device to closure ventricular septal defects of patients through the delivery system by transthoracic minimally invasive small incision without cardiopulmonary bypass.
干预措施: sufentanil anesthesia (Drug)
Off-pump hybrid closure
Hybrid closure is that a periventricular technique uses an occluding device to closure ventricular septal defects of patients through the delivery system by transthoracic minimally invasive small incision without cardiopulmonary bypass.
干预措施: Hybrid closure (Procedure)
Control
Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.
干预措施: sufentanil anesthesia (Drug)
Control
Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.
干预措施: Control (Procedure)
结局指标
主要结局
Respiratory dysfunction as measured by PaO2
时间窗: 7 days postoperatively after cardiac surgery
Myocardial injury as measured by cardiac troponin I serum
时间窗: 7 days postoperatively after cardiac surgery
次要结局
- All cause mortality(7 days postoperatively after cardiac surgery)
研究者
Hong Liu
Principal Investigator
The First Affiliated Hospital with Nanjing Medical University