A Randomized Controlled Trial Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure
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
- Time to complete the standard versus the US-guided procedure
研究概览
简要总结
This is a randomized controlled study comparing US guided vs standard procedure for PICC line placement in newborns admitted to Children's Hospital of Eastern Ontario Neonatal Intensive Care Unit who require a PICC line. Patients will be randomized using REDCap randomization module (stratified by gestational age < 28 weeks and >= 28 weeks and blocked to ensure approximate balance with each stratum) into two arms. - Arm 1: PICC line insertion procedure using anatomical landmarks and tip placement will be confirmed by X-ray (current standard); Arm 2: US guided PICC line insertion procedure and tip placement confirmation by both US and X-ray. Sample size of 33 infants per group would achieve greater than 80% power to detect a difference between groups.
Primary outcome: Time to complete the standard versus the US-guided procedure.
Secondary outcomes (comparison between two arms):
The number of total "venipuncture" attempts needed to place a PICC line Number of tip manipulations after complete insertion Proportion of successful tip placement
详细描述
Background Peripherally Inserted Central Catheter (PICC) line placement is one of the most commonly performed procedures in Neonatology. Due to prematurity and small vein size, the procedure often requires multiple attempts over an increased timeframe. As a standard of care, the position is confirmed by X-ray. Frequently, catheters are not optimally positioned, necessitating repositioning and further radiographs.
The use of ultrasound (US) guidance for PICC line placement enhances the visualization of the veins and provides a better selection for optimal access. It could decrease or even eliminate the need for X-rays when used to confirm the tip position.
Objectives To demonstrate that using US-guidance to place and confirm tip positioning for PICC line insertion in neonates will decrease the number of cannulation attempts, will shorten the time needed to complete the procedure, and will decrease infants' exposure to radiation.
Methods This is a randomized controlled study comparing US guided vs standard procedure for PICC line placement in newborns admitted to CHEO NICU who require a PICC line (approximately 130-150 infants per year). Patients will be randomized using REDCap randomization module (stratified by gestational age < 28 weeks and >= 28 weeks and blocked to ensure approximate balance with each stratum) into two arms - Arm 1: PICC line insertion procedure using anatomical landmarks and tip placement will be confirmed by X-ray (current standard); Arm 2: US guided PICC line insertion procedure and tip placement confirmation by both US and X-ray. A sample size of 33 infants per group would be sufficient to achieve greater than 80% power to detect a difference between groups.
Results of this study may demonstrate that US guided PICC line placement is superior (shorter and safer procedure, reduced radiation and pain) to currently used procedure and could lead to practice change.
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 28 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newborns (0-28 days) admitted to Neonatal Intensive Care Unit who require PICC line insertion after consent has been obtained to include in this study. Including:
- •Infants who need prolonged Total Parenteral Nutrition requirement of > 7 days.
- •Infants with difficult peripheral venous access who requires a central line
- •Infants who require IV medications for > 7 days.
- •Infants who require medications given by central IV access
- •Infants who will undergo complex surgical procedures and will require central IV access before procedure.
排除标准
- •Infants requiring isolation according to infection control protocols
- •Unable to obtain or refused consent for PICC line and/or study enrolment
- •Infants with any clinical contraindication for PICC line insertion as per unit policy
结局指标
主要结局
Time to complete the standard versus the US-guided procedure
时间窗: one year
Comparison between total time of procedure with standard approach vs US guidance measured in minutes.
次要结局
- Number of tip manipulations after complete insertion(One year)
- Proportion of successful tip placement(One year)
- Number of total venipuncture attempts needed to place a PICC line(One year)
研究者
Nadya Ben Fadel
Neonatologist
Children's Hospital of Eastern Ontario
