Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical performance and acceptability
研究概览
简要总结
The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Willing and able to independently sign an English Informed Consent
- •Have adequate veins for placement of IV catheters in both right and left upper extremities
排除标准
- •Currently taking anti-coagulation medication
- •Have a known bloodborne disease or bleeding tendency
- •Have a known fear or adverse reaction to needles or blood
- •Women who are pregnant or nursing
研究组 & 干预措施
ViaValve Safety IV Catheter
Catheter insertion using the ViaValve Safety IV Catheter.
干预措施: ViaValve Safety IV Catheter (Device)
Insyte Autoguard BC [Blood Control] Shielded IV Catheter
Catheter insertion using the Insyte Autoguard BC Shielded IV Catheter
干预措施: Insyte Autoguard BC [Blood Control] Shielded IV Catheter (Device)
结局指标
主要结局
Clinical performance and acceptability
时间窗: IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.
Primary outcome measure will be a composite of user ratings evaluating clinical performance and acceptability of each device via a 6-point Likert questionnaire.
次要结局
未报告次要终点