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

NCT ID: NCT01382524

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 682 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-09-30

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.

Detailed Description

See brief summary

Conditions

Catheter Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stabilization system A

A commercialized stabilization dressing using a winged PIV catheter.

No interventions assigned to this group

Stabilization System B

A commercialized stabilization device using a non-winged PIV catheter

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Solventum US LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randall Coombs, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Cedric Lefebvre, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

05-011427

Identifier Type: -

Identifier Source: org_study_id