Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems (PIV Secural)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Peripheral I.V. Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems|
- PIV Catheter complication rates [ Time Frame: Anticipated to be up to 4 days per participant ] [ Designated as safety issue: No ]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.
- Cost effectiveness [ Time Frame: Anticipated to be up to 4 days per participant ] [ Designated as safety issue: No ]The secondary endpoints are overall and specific complication rates, incidence of unscheduled restarts, incremental cost effective ratio for one stabilization system to another stabilization system.
|Study Start Date:||June 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Stabilization system A
A commercialized stabilization dressing using a winged PIV catheter.
Stabilization System B
A commercialized stabilization device using a non-winged PIV catheter
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382524
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States|
|Principal Investigator:||Randall Coombs, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Cedric Lefebvre, MD||Wake Forest University|