Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Delay in Therapy
研究概览
简要总结
A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no SafeBreak Vascular) to determine SafeBreak Vascular's impact on IV clinical care and complications.
详细描述
This randomized clinical trial's goal is to determine SafeBreak Vascular's impact, a break-away connector that separates when a harmful force is placed on a peripheral IV line, on IV clinical care and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The use of devices is randomly assigned to subjects in the study, but it is not possible to blind the patient, the care providers, the investigators or the outcomes assessor as to which group received the study device.
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
- •All patients admitted into the participating hospital units
- •Patients of any gender may participate
- •Participants able to provide informed consent or have a legally authorized representative immediately available to provide informed consent
- •Patients must have peripheral IV catheter access or need and are planned to have peripheral IV catheter access placed that is anticipated to last a minimum of 24 hours.
- •Patients must be receiving intermittent or continuous infusion or have immediate plans to begin an intermittent or continuous infusion
- •The patients must be at least 18 years of age with no upper age limit
排除标准
- •Unable to obtain informed consent or without an available Legally Authorized Representative or Next of Kin to provide surrogate informed consent
- •Age less than or equal to 17
- •Patient on comfort care only
- •Predicted to have an IV infusion that lasts less than 24 hours
- •Patient admitted from the Emergency Department refuses to have new peripheral IV catheter placed by IV team
- •Patient has two or more peripheral IV catheters at the same time
- •Patient enrolled in a subject drug or device study at the time of enrollment
- •Investigator discretion that patient is not suitable for the study
- •Patient is COVID-19 positive
- •Patient is receiving an IV infusion with gravity tubing
结局指标
主要结局
Delay in Therapy
时间窗: Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first
A comparison in delays in therapy between the control group and the intervention group.
次要结局
- Estimate the Impact for Other Peripheral IV Complications.(Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first)