Feasibility Study for ivWatch® in Prevention of Extravasation of Vesicants in an Oncology Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Detection of extravasation in patients wearing ivWatch
研究概览
简要总结
This study aims to determine the feasibility of using the ivWatch (registered trademark) device to determine if there is an infiltration at the site of a peripheral intravenous (PIV) catheter. An infiltration is when the IV fluid leaks out of a vein and into the surrounding tissue. If medication starts leaking outside the vein, it can cause damage to the surrounding tissue. Using the ivWatch device may identify leaking fluid before the nurse is able to visually observe the signs or symptoms of the leaking fluid.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the feasibility of using the ivWatch device to detect extravasations of peripheral vesicants given in an adult oncology ambulatory population.
SECONDARY OBJECTIVE:
I. Evaluate the clinical outcomes of extravasations that occur with the use of the ivWatch device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring a peripheral IV for infusion of vesicant or vesicant-like agents (chemotherapy, other vesicant medications).
- •PIV must be inserted
- •Participant (or legal representative) must understand the nature of this study and verbally consent with the Research Study Information Sheet prior to receiving any study related procedure
排除标准
- •Patients who are not getting a vesicant, irritant or vesicant like fluid infused.
- •Patients who are bruised, scarred, or tattooed in the area of the PIV.
- •Patients with skin integrity issues at the site of the PIV.
- •Patients who are on "light precautions."
- •Not for use in power injectors.
- •Not for use on mediports, implanted ports, IVAD, central lines, PICC lines.
- •Patients without a cancer diagnosis.
研究组 & 干预措施
Medical Device Usage
Patients utilize ivWatch device at time of already scheduled chemotherapy on study
干预措施: ivWatch (Device)
结局指标
主要结局
Detection of extravasation in patients wearing ivWatch
时间窗: Up to 1 year
Evaluated by the ratio of number ivWatch used for vesicant therapy over the total number of vesicant therapies for study participants
次要结局
- Change in number of extravasations while wearing ivWatch(Up to 1 year)