A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- IV dislodgement rate
研究概览
简要总结
SafeBreak Vascular is a medical device indicated for fluid flow control during the administration of IV fluids/medication to the patient's vascular system and to aid in the prevention of unintended disruption and dislodgment of IVs. SafeBreak Vascular may be used for any hospitalized patient with gravity tubing or IV pumps, for intermittent infusion or continuous infusion.The primary objective of this study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing.
详细描述
Study participants will have a SafeBreak Vascular installed in each of their existing or newly installed IV lines. The clinical literature shows in prospective observational studies that a mean of 9.2% of patients dislodge their peripheral IVs. SafeBreak Vascular is a medical device designed to aid in the prevention of unintended disruption and dislodgement of IVs, such as peripheral IVs, peripherally inserted central lines, central lines, etc. SafeBreak IV will be installed in each IV line between the study participant's catheter and the IV tubing that goes to the IV bag or IV pump. When a harmful force is placed on the IV line, SafeBreak Vascular is designed to separate so that the harmful force is removed from the line and IV dislodgement is prevented. SafeBreak Vascular has a valve in each end of the device. Upon separation, each valves closes, stopping the flow of fluid. The primary objective of the study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing. The number of IV dislodgements and IV restarts will be recorded. The study will also collect data for analysis concerning the following:
- device design characteristics
- certain human factors (patient or operator) associated with the use of the device
- the impact of this device usage on clinician workflow
- any unknown safety concerns
- obtain preliminary data for use in designing a subsequent pivotal study of the 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Geriatric trauma patients (> or equal to age 55)
- •Participants able to provide informed consent or have a legally authorized representative (LAR) provide consent
- •The patients must have IV access (existing central venous catheter, peripherally inserted central catheter, or peripheral IV's) or need IV access
- •The patients must be at least 55 years of age.
排除标准
- •Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
- •Age less than or equal to 54
- •Patient on comfort care only
- •Predicted to have less than 24 hours survival
- •Patient enrolled in an investigational drug or device study at the time of enrollment
- •Investigator discretion that patient is not suitable for the study
结局指标
主要结局
IV dislodgement rate
时间窗: Up to 7 days
Compare the study intervention's rate of IV dislodgement to the clinical literature's prospective observational studies that have a mean dislodgement of 17.5% and median of 9.2%.
次要结局
- IV restarts(Up to 7 days.)
- Device related adverse events(Up to 7 days)