Feasibility Study to Assess the Safety and Efficacy of the ViTal Peripheral Intravenous Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- First attempt success rate
研究概览
简要总结
The goal of this clinical trial is to assess the safety and efficacy of ViTal, a peripheral intravenous catheter with a glide-on-contact design of the plastic canula tip, in peripheral intravenous catheterization in individuals requiring intravenous therapy or blood sampling. The main question it aims to answer is:
What is the first attempt success rate of the peripheral intravenous catheterization done using the study device?
Participants will be asked to grade the pain they experienced when attempts were made to insert the study device into their peripheral vein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age ≥
- •Requiring blood sample collection (roll-in subjects) or planned for PIVC (analyzable subjects)
- •Signed informed consent.
排除标准
- •Pregnancy or lactation.
- •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.
研究组 & 干预措施
GPIV
If the eligibility criteria are fulfilled, up to 4 attempts will be made to achieve successful peripheral intravenous catheterization with the investigational device. All successive attempts will be made at a site different from the one(s) at which access has already failed.
干预措施: GPIV (Device)
结局指标
主要结局
First attempt success rate
时间窗: Periprocedural
Proportion, in percent, of subjects with successful peripheral intravenous catheterization Successful PIVC is defined as withdrawal of non-pulsatile blood or infusion of saline without evidence of extravasation. Failed PIVC is defined as extravasation with initial infusion, inability to draw blood, physician or nurse intervention for access or inability to obtain access.
次要结局
- Device- and procedure-related adverse events(Periprocedural)