Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns : Insertion on Micro-guide Versus Conventional Insertion, Without Micro-guide
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Success of peripheral venous catheterization at the first attempt
研究概览
简要总结
Peripheral venous catheterization represents the preferential option for term or preterm infant care in order to start drug treatment or hydration, or perform anesthesia.
However, the peripheral venous access is associated in approximately 50% of cases with a failure of the insertion on the first attempt in an emergency context. Using a micro-guide may facilitate the peripheral venous catheterization in newborns, by guiding the catheter in the vein and, thereby reduce the risk of transfixion of the vascular lumen.
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
- Single (Investigator)
盲法说明
Peripheral venous catheterization is perform by a nurse. The placement characteristics are evaluated by the investigator, blind of the condition of placement if possible.
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital
排除标准
- •Term neonate > 28 days
- •Premature neonate > 41 weeks of corrected gestational age
- •Exclusive requirement for an umbilical venous catheter, in the context of neonatal resuscitation
- •Exclusive requirement for an epicutaneous-cava catheter, in the context of prolonged parenteral nutrition.
研究组 & 干预措施
Insertion of peripheral venous catheter with micro-guide
干预措施: Insertion of peripheral venous catheter with micro-guide (Device)
Classic insertion of peripheral venous catheter, without micro-guide
干预措施: Classic insertion of peripheral venous catheter, without micro-guide (Other)
结局指标
主要结局
Success of peripheral venous catheterization at the first attempt
时间窗: Up to 5 minutes after the success of the placement
The success of the placement is defined by the arrival of blood in the transparent chamber downstream of the needle during the placement, and by the absence of painful reaction and edema near the insertion site, indicating extravasation or extravascular passage, after flushing the catheter with 0.5 to 1 ml of isotonic saline. The success will be confirmed by retesting flush after securing the peripheral venous catheter in a dressing, within 3 to 5 minutes of successful puncture.
次要结局
- Adverse events(Up to 1 month.)
- Efficiency of the technique(Up to 4 days.)
- Adverse events(Up to 4 days.)