Point-of-care Ultrasound for Difficult Peripheral Vascular Access in the Emergency Department - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- number of attempts of each peripheral i.v. access placement
研究概览
简要总结
Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). The research hypothesis is that a biplane sonographic approach (i.e., an out-of-plane and in-plane view) might be superior to a mono-plane approach (i.e., an out-of-plane or in-plane view) obtaining a peripheral vascular access among difficult patients admitted to the ED
详细描述
Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). In some studies, difficult vascular access population was about 33% of evaluated patients and for most of them the "blind" method (i.e., palpation) fails in the line insertion. Ultrasound guidance often increase the success rate among these patients.
Two basic techniques were proposed for sonographic guidance, a transversal or a longitudinal approach to the chosen vessel (i.e., out-of-plane or in-plane view, respectively, "mono-plane" approach).
The availability of hand-held sonographic devices is increasing the number of emergency department were this guidance is used in a difficult vascular access population.
The Butterly iQ+ device is now able to show out-of-plane and in-plane views, simultaneously, the so called bi-plane view.
Aim of this randomized controlled trial is to test if a bi-plane sonographic vision might be able to increase the performance of trained operators in obtaining a peripheral vascular access among difficult patients admitted to the ED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one of the following criteria have to be present along with the need for a peripheral access
- •chronic renal disease/ongoing dialysis;
- •sickle cell anemia;
- •prolonged and/or frequent use of i.v. drugs;
- •difficult vascular access (after a first attempt or self-reported);
- •previously need for more than one attempts / ultrasound guidance for getting a peripheral vascular access.
排除标准
- •no consent to participate in the study.
结局指标
主要结局
number of attempts of each peripheral i.v. access placement
时间窗: Through study completion, likely of 1 year and half
The number of attempts needed for getting a peripheral i.v. access will be measured
Time needed for each peripheral i.v. access placement
时间窗: Through study completion, likely of 1 year and half
Time needed for for getting a peripheral i.v. access will be measured
次要结局
未报告次要终点
研究者
Emanuele Pivetta
Staff physician
A.O.U. Città della Salute e della Scienza