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临床试验/NCT03474978
NCT03474978招募中不适用

Peripherally Inserted Central Venous Catheter Insertion Site and Complication Rates in Neonates

University of Calgary2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2018年10月19日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amuchou Soraisham

Neonatologist

University of Calgary

研究点 (2)

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