Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Average length of stay on site of the catheter measured in hours
研究概览
简要总结
The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge catheters Will be included in the study.The study will assess in particular:
- the difference of permanence in situ of the device
- the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation)
- the difference in costs between use of saline normal saline 0.9% NaCl solution and heparinized 50 U / ml.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 years and 14 years old
- •Medical prescription of intravenous antibiotic therapy for at least 2 doses on the day
- •Presence of informed consent to participate to the study provided by the parents
- •No known hypersensitivity to heparin
- •No known hypersensitivity to the patch fixing materials (polyurethane and / or glue)
- •Absence of diseases buoyancy coagulation (haemophilias and / or thrombophilias)
- •No antecedents trombopenie dued to the use of any type of heparin or a pentosan polysulfate
- •No existing treatment based on corticosteroids and / or anti-inflammatory
排除标准
- •age outside the range 2 - 14 years
- •children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day
- •children for which the parents have not consented to the study
- •children with known hypersensitivity to heparin
- •children with known hypersensitivity to the patch fixing materials (polyurethane and / or adhesive)
- •children with disease-causing buoyancy coagulation (Hemophilia and / or thrombophilia)
- •children with antecedents of trombopenie occurring by the use of any type of heparin or of a pentosan polyphosphate
- •children in treatment with corticosteroids and / or anti-inflammatory
研究组 & 干预措施
0,9% NaCl flush
for children enrolled in this group, the nurse will perform the flushing of peripheral venous catheter using flush-solution as a bolus with saline 0.9% NaCl in the amount (ml) needed to fill the entire circuit of the catheter. The flushing will be performed routinely at the end of each fleboclisis
干预措施: 0,9% NaCl flush (Drug)
Heparin 50U/ml
for children enrolled in this group, the nurse will perform the washing of peripheral venous catheter using flush-solution as a bolus with heparin 50U/ml in the amount (ml) needed to fill the entire circuit of the catheter. The washing will be performed routinely at the end of each fleboclis
干预措施: Heparin 50U/ml (Drug)
结局指标
主要结局
Average length of stay on site of the catheter measured in hours
时间窗: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 dayse
次要结局
- Incidence of complications extimated overall and by type of complication(participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days)
- Average cost for the maintenance of the catheter of each subject (pro day and in total)(participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days)
研究者
Filippo Festini
Professor of Nursing
University of Florence