Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device
试验速览
- 阶段
- 1 期
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml
研究概览
简要总结
Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. It acts as a physical barrier from touch and airborne contamination for up to 96 hours. This product has been endorsed and will be adopted for use at NorthShore University HealthSystem as a quality improvement initiative. This research study protocol is designed to confirm the anticipated benefit of this change in practice at NorthShore during the planned implementation and use.
If the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled.
排除标准
- •Minors and adult inpatients without PICCs or with PICCs for < 5 days
研究组 & 干预措施
Glenbrook Hospital
Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only.
干预措施: Disinfecting Cap (Device)
Evanston, Highland Park, Skokie Hospitals
Phase 1: Assess baseline contamination rate for patients with PICC catheters for 3-12 months.
Phase 2: Implement intervention. Assess contamination 3-12 months. Phase 3: (optional): Remove cap asses contamination rate (3-6 months)
干预措施: Disinfecting Cap (Device)
结局指标
主要结局
Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml
时间窗: Throughout the study with enrolled subjects (The catheter must have been in place for a period of 5 or more days before the first sample is taken.)
For the research project, we will monitor the colonization of access port colonization in routine as well as SwabCap™ cared for lines as follows: Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube.
次要结局
- Central line associated bloodstream infections(Throughout the study and from historical data)