NCT02213965已完成不适用
Clinical Investigation Acc. to MPG §23b: Open-label Prospective Study Comparing the Handling of the Handling of Two Peripheral IV Catheter (PIV) Systems (Ported and Non Ported) in Randomized Order
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,340
- 试验地点
- 2
- 主要终点
- Incidence of successful puncturing on the first attempt
研究概览
简要总结
A peripheral intravenous catheter is the most commonly used vascular access device in medicine. Primary objective is to compare insertion and handling of two peripheral intravenous catheters in clinical routine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of successful puncturing on the first attempt
时间窗: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
次要结局
- Rate of insertion failures(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)
- For Vasofix Safety: Rate and nature of use of application port(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)
- Rate and number of recannulation(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)
- Incidence of needle stick injuries(During catheter fixation)
- Rate of adherence to standard application requirements of catheter placement(During catheter fixation until directly after catheter fixation)
- General judgment of catheter (school class grading)(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)
- Rate of difficulties to insert catheter and to withdraw the needle with regard to:Penetration characteristics of the needle, insertion and movement of catheter(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)
- Rate and number of testing of ease of moving(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)
- Rate, number and kind/extend of blood emission(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)
- Condition of fixation after completion of catheter insertion(During catheter fixation until directly after catheter insertion)
- Adverse Events(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)
研究者
研究点 (2)
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