Peripheral Intravenous Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems

NCT01382524 | Completed

• 1 other identifier: 05-011427
• Study Type: observational
• Target: 682
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Catheter Complications

Keywords

PIV therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost effectiveness

  Anticipated to be up to 4 days per participant

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Location

Study Officials

• Randall Coombs, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Cedric Lefebvre, MD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

US (2)