Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)
研究概览
简要总结
This study will enroll up to 192 children less than 18 years of age, who will receive electrocardiographic guidance for placement of a PICC in addition to radiography done as standard care. The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.
详细描述
The placement of peripherally inserted central catheters (PICCs) is an important component of medical care for a variety of patients. Current practice requires radiographic confirmation of catheter tip placement prior to use of the line for administration of medications. Often the final catheter tip position may be uncertain based on radiographic imaging. Other times, the catheter is malpositioned and requires adjustment and repeat radiographic imaging. In adult patients, a system of confirmation that is based on electrocardiographic activity has been implemented and is FDA approved. This study will enroll up to 192 children less than 18 years of age who will receive electrocardiographic guidance for placement of a PICC, in addition to radiography done as standard care. The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from birth to 17 years in need of a PICC as part of the medical treatment plan
- •Suitable for an upper extremity PICC placement
- •Hemodynamically stable, including patients stable on vasopressors
排除标准
- •Hemodynamic instability
- •Cardiac abnormality which leads to abnormal p-wave on ECG
- •Arrhythmia at baseline, documented duirng the current hospital admission
- •Presence of pacemaker or pacing wires which are currently actively pacing
- •Patients who have undergone reconstructive cardiac surgery and/or have anatomic variance that would affect the location of the sinoatrial node in relation to the superior vena cava
- •Premature neonate (<37 weeks estimated gestational age)
- •Placement of PICC in lower extremity
结局指标
主要结局
Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)
时间窗: Less than 24 hours
Successful placement (based upon review of chest radiograph) of the PICC as determined by the tip location of: * RA SVC junction (right atrium/superior vena cava) or * Distal or lower SVC
次要结局
未报告次要终点
研究者
Michael Agus
Principal Investigator
Boston Children's Hospital