A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- First attempt success rate
研究概览
简要总结
A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.
详细描述
The OptiVein IV Catheter is a sterile single use disposable intravascular cannulation device that is modified from CE certified Vasofix Certo Catheter from B.Braun with the additional features of an optical fiber and modified flashplug. The OptiVein System also includes an electronic unit.
The OptiVein Catheter shares a similar intended use and the same catheter components as the Vasofix Certo IV Catheter. Clinical data will be obtained to demonstrate that there is no change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter.
A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.
Patients aged newborn to twelve (12) years requiring short-term use of an IV catheter to withdraw blood samples or to administer fluids or medications intravenously.
Participating sites will follow routine practice guidelines regarding the personnel responsible for inserting the catheters for this study, known herein as "operators." Operators must be professionally trained in IV catheter placement; educational background and level of experience of operator will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged newborn to 12 years
- •Has written or verbal order for insertion of an IV
- •Requires peripheral IV therapy (catheter)
- •Has an insertion site in the forearm, hand, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
- •Demonstrates cooperation with a catheter insertion and the study protocol
- •Informed consent has been obtained
排除标准
- •Life expectancy less than 72h.
- •Any child the research staff deem unobservable
- •The study IV catheter site will be placed below an old infusion site
- •Will likely require a power injection for a radiologic procedure during participation in this study
研究组 & 干预措施
OptiVein
Placement of IV-catheter and administration of treatment using OptiVein catheter.
干预措施: OptiVein Catheter (Device)
Vasofix Certo
Placement of IV-catheter and administration of treatment using Vasofix Certo catheter.
干预措施: Vasofix Certo Catheter (Device)
结局指标
主要结局
First attempt success rate
时间窗: Immediate / During the procedure usually taking less than 1 minute
Successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
次要结局
- Number of attempts(Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes)
- Incidence of infection(72 hour follow-up or time of removal of catheter, whichever occurs first)
- Time to successful IV insertion(Immediate / During the procedure usually taking less than 1 minute if successful with first stick or within 30 minutes if further attempts are required)
- Incidence of blood extravasation resulting in a hematoma(Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first)
- Unplanned withdrawal of IV catheter(72 hour follow-up or time of removal of catheter, whichever occurs first)
- Overall complication rate composed from #2-5 above(72 hour follow-up or time of removal of catheter, whichever occurs first)
- Incidence of fluid extravasation delivered through catheter(Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first)