Randomized Control Study to Evaluate Impact of the Use of Cyanoacrylate Glue on PICC Line Dressing Care in the Infant Cardiac Care Unit at Children's Hospital of New York
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Duration of Longevity of PICC Line Dressing
研究概览
简要总结
This study will evaluate whether applying micro drops of cyanoacrylate glue to the participant's peripherally inserted central catheter (PICC) insertion site prior to covering the area of PICC line with a transparent film dressing will make the PICC dressing last longer and prevent an occurrence of PICC line moving out of its original placement. The investigators aims to evaluate whether 1) using the cyanoacrylate glue will lengthen the time to first dressing change; and 2) participants in the experimental arm (glue used) will have fewer dressing changes per week compared to the control arm (standard care) during admission.
详细描述
The neonatal population poses a unique challenge due to the small surface area of PICC sites, underdeveloped skin layer, and inability to contain the child's movements during a dressing change.
PICC line migration is the most common complication of PICC line maintenance in the neonatal intensive care unit (NICU). Previous studies have found that the PICC migration/dislodgment mostly occurs during PICC dressing changes among the neonatal population.
Recent published studies demonstrated that medical tissue adherence glue, Cyanoacrylate, significantly reduces the incidences of catheter migration and insertion site bleeding of PICC lines in all age of patients including premature infants.
The proposed study is a randomized control study with aimed data collection of 60 participants; of the 60 participants, 50 participants' data are to be used for statistical analysis and additional 10 participants to account for withdrawals.
The participants will be randomly assigned to one of two groups: one (the control group) receiving our standard PICC dressing method and the other (the study group) receiving cyanoacrylate glue at the PICC insertion sites prior to applying a standard transparent film dressing over the PICC sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the 9 North intensive coronary care unit (ICCU) at NewYork-Presbyterian Morgan Stanley Children's Hospital greater than 35 weeks of corrected gestational age who have a PICC line placed by a NICU provider.
排除标准
- •Any patient with a PICC line in situ from an outside hospital.
- •Any patient with a PICC line placed by an outside department, namely the interventional radiology department.
- •Any patient with a PICC line that is silicon material catheter, such as Vygon Epicutaneo-Cava catheter because of limited accuracy of measuring a movement of the catheter migration after 25 centimeter mark due to absence of a centimeter mark on the catheter.
研究组 & 干预措施
Control Group
This group will be received the current standard of care (SOC) dressing method for PICC lines.
干预措施: Standard transparent film dressing (Device)
Cyanoacrylate Glue Group
This group will receive a few drops of cyanoacrylate glue on PICC line site prior to application of usual standard film dressing over the PICC line site.
干预措施: Cyanoacrylate glue (Device)
Cyanoacrylate Glue Group
This group will receive a few drops of cyanoacrylate glue on PICC line site prior to application of usual standard film dressing over the PICC line site.
干预措施: Standard transparent film dressing (Device)
结局指标
主要结局
Duration of Longevity of PICC Line Dressing
时间窗: Up to 7 days
Duration of longevity defined as the number of days the PICC line dressing lasts from the scheduled dressing change.
次要结局
- Number of PICC Line Migrations(Until PICC line removal (approximately 12 weeks))
研究者
Marianne Garland
Associate Professor of Pediatrics
Columbia University