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

Catheter Complications Clinical Trial

— PIV Secural  

Official title:

Peripheral I.V. Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382524
• Other study ID #: 05-011427
• Status: Completed
• Phase: N/A
• First received: June 24, 2011
• Last updated: June 12, 2013
• Start date: June 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

See brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 682
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Catheter Complications

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No