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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01382524
First received: June 24, 2011
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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.


Condition
Catheter Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peripheral I.V. Catheter Complication Rate Comparison of Two Different Catheter-Stabilization Systems

Further study details as provided by 3M:

Primary Outcome Measures:
  • PIV Catheter complication rates [ Time Frame: Anticipated to be up to 4 days per participant ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cost effectiveness [ Time Frame: Anticipated to be up to 4 days per participant ] [ Designated as safety issue: No ]
    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.


Enrollment: 682
Study Start Date: June 2011
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382524

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Randall Coombs, MD University of North Carolina, Chapel Hill
Principal Investigator: Cedric Lefebvre, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01382524     History of Changes
Other Study ID Numbers: 05-011427
Study First Received: June 24, 2011
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 3M:
PIV therapy

ClinicalTrials.gov processed this record on July 22, 2014