Effect of Ultrasound-guided Insertion of Peripheral Catheters in the Forearm in Complications Incidence.
试验速览
- 阶段
- 不适用
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Number of participants presenting peripheral catheter insertion-related complications for each intervention
研究概览
简要总结
The purpose of this study is to compare the appearance of complications after the insertion of peripheral venous catheters with two different techniques (traditional and ultrasound-guided).
详细描述
All patients, whose parents were informed about the study and give written informed consent, will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to visualization/palpation or ultrasound-guided peripheral catheter insertion. All participants undergo a 10 days monitoring of the catheter status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
A random list is generated by a computer randomizer program. Sealed numbered envelopes are prepared with study documents and the technique to be performed. Investigators take envelops in consecutive order as long as participants accept to be included in the study
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 0 and 18 years
- •Patients in need of a peripheral venous catheter
排除标准
- •Inability of insertion in both forearms (i.e. burnt, amputation)
- •Patients in need of a central venous catheter
结局指标
主要结局
Number of participants presenting peripheral catheter insertion-related complications for each intervention
时间窗: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Peripheral insertion-related complications: phebitis, infiltration, catheter loss, obstruction
次要结局
- Demographic traits of participants presenting peripheral catheter-related complications(From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days)
- Use of the catheter inserted in participants presenting peripheral catheter-related complications(From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days)
- The proportion of canalization aspects in peripheral catheter-related complications(From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days)
- Number of participants that present immobilization of the limb in both techniques(From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days)