跳至主要内容
临床试验/NCT01382524
NCT01382524已完成不适用

Peripheral I.V. Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems

Solventum US LLC2 个研究点 分布在 1 个国家目标入组 682 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
682
试验地点
2
主要终点
PIV Catheter complication rates

研究概览

简要总结

Approximately 300 million short peripheral intravascular catheters (PIVs) were sold in the U.S. in 2009. These short (< 3 inches) peripherally inserted IV catheters are vital for providing patients with needed: 1) fluid, electrolyte, nutrient and blood product replacement, 2) medicines and 3) diagnostic solutions (dyes). However, these IV catheters have inherent risks or potential complications which may result from poor catheter securement or stabilization.

When a PIV catheter is not properly secured, motion and micro-motion within the vessel cause injury to the vein. This damage to the vein is a primary cause of phlebitis, a distressing complication of PIV therapy. Additional complications of inadequate stabilization of the PIV catheter are infiltration, leaking at the insertion site, pain, infection and dislodgement. According to Royer (2003), the most common reason for PIV catheter failure is infiltration and dislodgement. Infiltration is more dependent on keeping the extremity still, where phlebitis is dependent on injuries due to the chemical nature of the drugs and fluids infused or by the physical trauma to the endothelium from IV pushes.

The results of these complications are costly and can be serious if another vein cannot be immediately accessed or if the infiltrated infusate causes tissue necrosis. An unscheduled restart of another PIV catheter causes a delay in patient treatment, patient discomfort, patient dissatisfaction, safety concerns, nursing interruptions and additional costs. Actual costs associated with PIV catheter restarts include materials and nursing resources; yet intangibles such as, treatment for patient complications and patient dissatisfaction may be far more costly.

One way to reduce the incidence of PIV catheter-associated complications is to use technologies that help reduce catheter movement thereby improving catheter stabilization. In addition to stabilization platforms added to the peripheral IV catheter design, catheter stabilization devices and modified transparent film dressings also help to reduce catheter movement and could possibly eliminate the need for routine catheter site changes.

Therefore, the purpose of this study is to: 1) compare the number of PIV securement-related complications and PIV catheter restarts of one stabilization system to another stabilization system and 2) to determine which system provides a cost savings.

详细描述

See brief summary

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age, unless an emancipated minor
  • A patient who is admitted or going to be admitted to the hospital
  • Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer.
  • Has an insertion site in the forearm or hand free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
  • Demonstrates cooperation with a catheter insertion and the securement protocol.

排除标准

  • Is a current participant or a past participant in this study
  • If the study PIV catheter will cross a joint or the catheter hub will hang off the fingers
  • If the study PIV catheter site will be placed below an old infusion site
  • If the study PIV site needs to be immobilized with a splint or other devices
  • Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes or liquid skin protectants
  • Requires the application of a gauze pad, a topical ointment or solution under the dressing in addition to the prep(s) required in the protocol
  • Has or has had a previous IV catheter related phlebitis or infiltration during this hospitalization.
  • Will have a vesicant administered through the study catheter, e.g. Dilantin
  • Will require a power injection for a radiologic procedure during participation in this study

结局指标

主要结局

PIV Catheter complication rates

时间窗: Anticipated to be up to 4 days per participant

The primary endpoint for the study is the difference between the number and type of PIV-related complications (phlebitis, infiltration, dislodgement, leakage, local site infection and catheter line associated infection) between the two stabilization groups.

次要结局

  • Cost effectiveness(Anticipated to be up to 4 days per participant)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验