Ultrasound Guided Diagnosis of Central Venous Catheters in Children: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Diagnosis of the correct central venous catheter position.
研究概览
简要总结
After the placement of a central venous catheter in children, a routine chest X-ray will be performed in order to examine the correct position of the catheter. In this feasibility study the investigators intend to evaluate whether the ultrasound is as sufficient as the chest X-ray to verify the correct position of the central venous catheter in children with the purpose to prevent radiation on children in the future.
详细描述
For punctures of a central vein in very small children, ultrasound is an useful tool which allows for exact examination of the relevant anatomy in order to visualize the target vessel, so as to facilitate the puncture in real-time. However, to ascertain the correct position of the central venous catheter (CVC), a chest X-ray is still the gold standard. The main disadvantage of the X-ray is the children's exposure to radiation. That's why the investigators intend to perform this study whether the ultrasound is as sufficient as the chest X-ray to verify the correct position of a central venous catheter in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and children aged between 0 and 8 years requiring a central venous catheter. The planned sample size is 20 subjects. The indication for a CVC, will be determined by the attending physician.
- •Inclusion criteria:
- •Infants (inclusive early and late preterm) and children aged between 0 and 8 years
- •Necessity of a central venous catheter
- •Written informed consent given by parents after being provided with detailed information about the nature, risks, and scope of the catheterization
- •No legal incapacity and/or other circumstances rendering the parents unable to understand the nature, scope and possible consequences of the catheterization
排除标准
- •Parents refusal
研究组 & 干预措施
Ultrasound
Ultrasound for diagnosis of CVC position in children
干预措施: Ultrasound for diagnosis of CVC position in children (Procedure)
结局指标
主要结局
Diagnosis of the correct central venous catheter position.
时间窗: After all patients have been included (three months), all clips of each participant will be presented to three blind observers, classifying these clips for two times and outcome measure will be assessed.
Ultrasound imaging will be stored in mpeg format and deidentified for all examinations. The ultrasound movie will be split into five clips with a length of 5 seconds each (four clips with CVC not inserted but ultrasound head slightly moving and one clip with CVC in situ). The total of 110 clips is presented in random order to three blinded observers who classify these clips two times with a time gap of at least 2 weeks between the classifications.
次要结局
- Exclusion of a pneumothorax via ultrasound compared to chest X-ray(At 30 to 60 minutes after central venous catheter insertion each participant will undergo chest ultrasound and chest X-ray.)
研究者
Dr. Wolfgang Klug
MD
Medical University of Vienna