Peripherally Inserted Central Venous Catheter Insertion Site and Complication Rates in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Primary outcome is the presence of any complication which necessitates PICC removal
研究概览
简要总结
This study examines whether there is an association between the PICC insertion site and the complications necessitating PICC removal in neonates admitted to neonatal intensive care unit.
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
- — 至 4 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates of all gestational ages admitted to Foothills Medical Centre and Alberta Children's Hospital Neonatal Intensive Care Unit (NICU)
- •Peripherally inserted central venous catheter (PICC) line insertion planned as part of NICU care
- •Venous access available in both upper(above umbilicus) and lower body
排除标准
- •Local infection at potential site of insertion
- •Hemangioma, lymphangioma or malformations in the region of insertion
- •Major chromosomal anomalies
结局指标
主要结局
Primary outcome is the presence of any complication which necessitates PICC removal
时间窗: Through study completion, within 4 weeks
Line infiltration will be defined as extravasation of fluid into soft tissue around the region of the catheter tip. Line occlusion will be defined as inability to infuse fluid, resulting in removal of line. Phlebitis will be defined as presence of a linear red streak developing along the superficial veins from the catheter insertion site. Line associated thrombosis will be defined as ultrasound proven evidence of an occlusive thrombus in an anatomic location in proximity to the site of PICC.CLABSI will be defined according to Center for Disease Control definitions 26, that is, (1) confirmed primary bloodstream infection with (2) one of following clinical signs of infection (fever, hypothermia, apnea, or bradycardia) and (3) presence of central catheter at the time of or within 48 hours before the onset of the infection. Major life-threatening complications will include pleural effusion, pericardial effusion and cardiac tamponade, retroperitoneal extravasation.
次要结局
- Secondary outcome will be time to complication post insertion(Through study completion, within 4 weeks)
研究者
Amuchou Soraisham
Neonatologist
University of Calgary
