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

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.

Study Overview

• Status: Completed
• Conditions: Catheter Complications

Detailed Description

See brief summary

• Study Type: Observational
• Enrollment (Actual): 682

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Winston-Salem, North Carolina, United States
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PIV Catheter complication rates	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.	Anticipated to be up to 4 days per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness	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.	Anticipated to be up to 4 days per participant

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Principal Investigator: Randall Coombs, MD, University of North Carolina, Chapel Hill; Principal Investigator: Cedric Lefebvre, MD, Wake Forest University

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 13, 2013
• Last Update Submitted That Met QC Criteria: June 12, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: PIV therapy
• Other Study ID Numbers: 05-011427