Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems (PIV Secural)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382524
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 13, 2013
Information provided by (Responsible Party):

June 24, 2011
June 27, 2011
June 13, 2013
June 2011
June 2012   (Final data collection date for primary outcome measure)
PIV Catheter complication rates [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01382524 on Archive Site
Cost effectiveness [ Time Frame: Anticipated to be up to 4 days per participant ]
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.
Same as current
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Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems
Peripheral I.V. Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems

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.

See brief summary
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
The study population for this study will be male and female patients who are at least 18 years of age or an emancipated minor, require a peripheral IV catheter for an anticipated three days (72 hours) or longer
Catheter Complications
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  • 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Principal Investigator: Randall Coombs, MD University of North Carolina, Chapel Hill
Principal Investigator: Cedric Lefebvre, MD Wake Forest University
June 2013