The VISION STUDY: Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 1
- 主要终点
- Success or failure of peripheral IV placement on first attempt.
研究概览
简要总结
Children fear having an intravenous (IV) needle placed because of the pain that they will experience. The more needle punctures that a child has to endure before the IV is successfully placed, the greater the pain experienced and anxiety suffered. In addition, false starts increase the demands on medical staff and can increase the length of the emergency department stay. Often, veins are difficult to see or feel, particularly in an unwell, dehydrated child or in young infants who have more fat below the skin surface. Also, the venous pattern below the skin surface naturally varies from person to person and therefore success in placing IVs leaves room for improvement. Technology may be able to play an important role is improving the rates of success. The investigators wish to investigate whether the use of either an Ultrasound machine or a VeinViewer machine can improve the rate of success of the initial attempt (skin puncture) at peripheral IV placement in comparison to the current standard approach.
详细描述
Peripheral IV line placement is one of the most common and challenging painful procedures performed in the pediatric emergency department (PED). The lack of a clear visual guide for IV placement often leads to multiple painful attempts; delays in urgent treatment; increased use of human resources; increased costs; and increased anxiety in the patient, the parents and the staff. The research plan is a randomized controlled trial (RCT) to compare the use of two new technologies with the current standard method for vein location and IV placement in children.We would like to know if either of these technologies improve rates of successful IV placement on first attempt. Furthermore we would like to know if either technology leads to decreased time spent by staff on the procedure or decreased overall number of painful attempts. Information on nursing satisfaction, parental satisfaction and cost analysis will also be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 0-16 presenting to the Pediatric Emergency Department (PED)
- •Require IV as part of routine care
- •Knowledge of English language
排除标准
- •Child in critical condition
- •Child requires urgent IV placement
- •Central line available
研究组 & 干预措施
VeinViewer
The Veinviewer machine will be used to guide intravenous access.
干预措施: Veinviewer (Device)
Ultrasound
The Ultrasound will be used to guide intravenous access.
干预措施: Ultrasound (Device)
Conventional IV placement
IV will be placed using conventional technique
干预措施: Conventional technique (Other)
结局指标
主要结局
Success or failure of peripheral IV placement on first attempt.
时间窗: Within one hour of start of procedure
The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.
次要结局
- Time to successful placement of IV(Within one hour)
- Number of attempts to successful IV placement(Within one hour of start of procedure)
研究者
Sarah Curtis
Dr. Sarah Curtis
University of Alberta