Randomized Controlled Trial to Evaluate the Efficacy of Normal Saline Flushes at 12 and 24 Hours Intervals in Maintaining Peripheral Intravenous Catheters Patency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of participants with peripheral intravenous catheter patency
研究概览
简要总结
Children admitted in a ward often require a peripheral intravenous catheter to provide access for administration of medications, nutrients, fluids, blood products. Vascular access in children is a frequent and stressful procedure that should be performed as infrequently as possible in order to reduce the child's pain experience and the child's and family's level of distress. The maintenance of patency of indwelling catheters is therefore relevant to minimize need for replacement and children discomfort.
Recent studies investigated the most effective and safe method of maintaining peripheral intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the use of heparin versus saline flushes, showing similar efficacy of the two approaches.
To the best of the investigators knowledge no study addressed the issue of the optimal flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of normal saline flushes, at 12 and 24 hours intervals.
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 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 1 and 17 years
- •peripheral intravenous catheter 22 G or 24 G
- •need to maintain the access for at least 24 hours without infusion
排除标准
- •need for continuous infusion therapy
- •programmed therapy
研究组 & 干预措施
Flushing every 24 hours
Flushing with positive pressure with normal saline every 24 hours
干预措施: Normal saline (Drug)
Flushing every 24 hours
Flushing with positive pressure with normal saline every 24 hours
干预措施: Flushing with positive pressure (Procedure)
Flushing every 24 hours
Flushing with positive pressure with normal saline every 24 hours
干预措施: MicroClave ICU Medica (Device)
Flushing every 12 hours
Flushing with positive pressure with normal saline every 12 hours
干预措施: Flushing with positive pressure (Procedure)
Flushing every 12 hours
Flushing with positive pressure with normal saline every 12 hours
干预措施: Normal saline (Drug)
Flushing every 12 hours
Flushing with positive pressure with normal saline every 12 hours
干预措施: MicroClave ICU Medica (Device)
结局指标
主要结局
Number of participants with peripheral intravenous catheter patency
时间窗: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Patency was defined as the possibility of flushing the cannula with a 3 ml Becton Dickinson syringe filled with 3 ml of normal saline in less than 20 seconds without resistance at infusion, pain or erythema
次要结局
- Number of participants with skin redness(Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours)
- Number of participants with blood extravasation(Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours)
- Number of participants with pain(Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours)
- Number of participants with swelling(Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours)
研究者
Ronfani Luca
MD, PhD
IRCCS Burlo Garofolo