A Prospective, Randomized, Controlled Comparison of First Attempt Success Between the AccuCath Intravenous System With Retractable Coiled Tip Guide Wire and Conventional Peripheral Intravenous Catheters With Interventional Radiology Nurses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement
研究概览
简要总结
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
详细描述
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Male or female, age > or equal to 18 years or < or equal to 89 years old;
- •Capable and willing to give informed consent;
- •English speaking;
- •Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;
- •Admitted to study area.
排除标准
- •Male or female, < 18 years old or > 89 years old;
- •Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
- •Previous venous grafts or surgery at the target vessel access site;
- •Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
研究组 & 干预措施
Vascular access via study device
AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
干预措施: AccuCath IV Catheter System (Device)
Vascular access via control device
Conventional IV Catheter System (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
干预措施: Conventional IV Catheter System (Device)
结局指标
主要结局
First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement
时间窗: Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes
次要结局
- Patient Satisfaction Upon Successful PIV Placement(Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes)
- Clinician Satisfaction Upon Successful PIV Placement(Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes)