NCT06604026已完成不适用
An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 3
- 主要终点
- Device related adverse events
研究概览
简要总结
This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.
详细描述
This study is being conducted to generate clinical data to support the performance and safety of BD PosiFlush™ SafeScrub. The study data will be used for regulatory submission in EU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Any patient (≥18 years of age) in a high acuity hospital medical or surgical unit regardless of gender, with an eligible in-situ vascular access device and with a needleless access device (NAD). This includes patients who have a current VAD, whether it is newly placed or long-term access as part of their routine medical care. Eligible in-situ vascular access devices are peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs) and implanted venous access ports. Eligible NADs are stopcocks, Y-sites, and needle-free connectors.
- •Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access.
- •Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.
排除标准
- •Any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team.
- •Patients under the age of
- •Patients suffering hypernatremia and fluid retention, when the administration of sodium or chloride could be clinically detrimental as determined by the study investigator.
- •Patients with a known allergy to any of the followings as determined by the study investigator:
- •Any of the components or materials of BD PosiFlush™ SafeScrub device or BD PosiFlush™ SP Syringe, or
- •0.9% sodium chloride solution
- •Pregnant or breastfeeding women
- •Urine pregnancy test will be required for all women of childbearing age who want to participate in the study
研究组 & 干预措施
Treatment arm
Experimental
use of the BD PosiFlush™ SafeScrub device
干预措施: BD PosiFlush™ SafeScrub (Device)
Control Arm
Active Comparator
pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad
干预措施: BD PosiFlush™ (Device)
结局指标
主要结局
Device related adverse events
时间窗: 15 minutes
To assess the incidence of BD PosiFlush™ SafeScrub device-related adverse events up to 15 min after each access
次要结局
- Compliance rate of device scrubbing(15 minutes)
- Device success rate(15 minutes)
研究者
研究点 (3)
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