BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Primary Performance: To have successful vascular access either by cannulation or blood return.
研究概览
简要总结
This post-market study is being conducted to generate safety and performance data on the BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.
详细描述
This is an observational post-market, human subject study to evaluate the safety and performance of the BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology. Subjects will be recruited for participation based on need for IV catheter (midline catheters included) placement in a hospital setting.
Enrolled subjects will go through ultrasound-guided peripheral intravenous catheter (USGPIV) placement as part of their clinical care. USGPIV is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 years, or older
- •A patient who is a candidate for an ultrasound-guided peripheral intravenous catheter (midline catheters included) placement procedure using BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology as assessed per their clinician(s)
- •Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the subject
排除标准
- •Any patient in whom ultrasound procedure might interfere with medical care or create undue hardship
- •Known, or suspected, allergy to materials contained in the BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology or accessories that may come in contact with the patient
- •Localized skin, tissue, or other clinical factors that would prevent completion of the ultrasound procedure
- •Previous medical history that would prevent completion of the ultrasound procedure
研究组 & 干预措施
USGPIV
Patient who is a candidate for an ultrasound-guided peripheral intravenous catheter (USGPIV) placement procedure (midline catheters included) using BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology as assessed per their clinician(s)
干预措施: BD Prevue(TM) II (Device)
结局指标
主要结局
Primary Performance: To have successful vascular access either by cannulation or blood return.
时间窗: During the procedure
Successful access with the vascular access device, either by cannulation or blood return (\>=70% with a 95% confidence interval)
Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device
时间窗: During the procedure
The PrevueTM II system is able to visualize the target vasculature (\>=70% with a 95% confidence interval)
Primary Performance: To determine if BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology is able to provide visual needle tip location tracking to assist with insertion of the chosen vascular access device.
时间窗: During the procedure
CueTM Needle Tracking System is able to properly display the location of the needle tip during vascular access device access insertion (\>=80% with a 95% confidence interval)
Primary Safety: To determine the incidence of device related adverse events, experienced by patient or user, when using the BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology
时间窗: During the procedure and 15 minutes after the procedure
Rate of device related adverse events (\<2%).
次要结局
- Secondary Performance: To have successful first-attempt vascular access either by cannulation or blood return when using the BD PowerGlide Pro midline catheter.(During the procedure)