Efficacy of Ben-Guard Garment in Reducing the Frequency of Pediatric Central Line Complications: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Mean Number of CVC Fractures
研究概览
简要总结
Central venous catheter (CVC) insertion is a common surgical procedure performed in children for the delivery of nutritional support, medications, frequent blood draws or transfusions. Maintaining hygienic conditions is absolutely necessary in order to avoid contamination of the catheter and tubing to avoid bloodstream infections. Fractures in the tubing is a common complication that places children at increased risk for infections. In order to help keep the tubing stable to avoid fractures and dislodgements, a wearable device was created called Ben-Guard. This pilot study is being undertaken to determine if the Ben-Guard device will reduce the incidence and severity of adverse events in children requiring CVCs.
详细描述
Conduct a pragmatic pilot study of the Ben-Guard Catheter Safety Device in 40 pediatric patients with central venous catheters (CVC). Participants will be issued 3-5 garments, which are expected to be worn at all times. This study will be conducted over an 18 month period. Participants are expected to wear the garment daily for the duration of the study (or duration of their treatment if <18 months). Data will be reviewed every 3 months to measure the garment's acceptability and effect on the frequency of central line-associated complications. Outcomes will be compared to a matched retrospective cohort. This study will use the device consistent with the description as a registered FDA Class 1 device. The investigators are conducting this study to clinically and scientifically evaluate the device's ability to change the frequency of CVC fractures and CVC complications in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants age 0-10
- •medical disease or condition that requires a CVC for treatment, supportive care or nutritional support
- •English Speaking
排除标准
- •Any patient who received a non-tunneled CVC
- •Any patient who had a tunneled CVC placed from an outside institution
- •Age > 10
- •Patients that cannot communicate or read English
结局指标
主要结局
Mean Number of CVC Fractures
时间窗: Up to 18 months
compared to retrospective cohort
次要结局
- Mean CVC-related Total Healthcare Associated Costs(Up to 18 months)
- Mean Number of CVC Dislodgements(Up to 18 months)
- Total Number of Central-Line Associated Blood Stream Infections (CLABSIs)(Up to 18 months)
- Total Number of CVC-related Emergency Department or Urgent Care Visits(Up to 18 months)