A Medium-term Venous Access Alternative in Infants Undergoing Congenital Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Days of complication-free use. Morbidity (infection, malposition, bleeding, thrombosis, need for removal for catheter-related complication). Need for additional catheter placement or reintervention.
研究概览
简要总结
This study is designed to evaluate medium-term central venous catheter placement in infants undergoing complex cardiac surgery using a new technique. This technique involves placement of the catheter into the inferior vena cava through a subcutaneous tunnel and through a tunnel between pericardium and diaphragm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 365 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants undergoing surgical correction or palliation of congenital heart disease via sternotomy
- •Age 0-365 days
- •Anticipated intensive care stay over 10 days
- •Need for central venous access or prolonged venous access
排除标准
- •Presence of access that is likely to last more than 10 days at time of operation
- •Septic shock
- •Known inferior vena cava thrombosis
- •Operations not approached by sternotomy
结局指标
主要结局
Days of complication-free use. Morbidity (infection, malposition, bleeding, thrombosis, need for removal for catheter-related complication). Need for additional catheter placement or reintervention.
时间窗: Until catheter no longer needed; it is not anticipated that these remain longer than 2 weeks. Prior to discharge all will have been removed and final assessment of primary outcome will be obtained
次要结局
未报告次要终点
研究者
David Bichell
Professor
Vanderbilt University Medical Center