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

12 de junio de 2013 actualizado por: 3M

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.

Descripción general del estudio

Estado

Terminado

Descripción detallada

See brief summary

Tipo de estudio

De observación

Inscripción (Actual)

682

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PIV Catheter complication rates
Periodo de tiempo: Anticipated to be up to 4 days per participant
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cost effectiveness
Periodo de tiempo: Anticipated to be up to 4 days per participant
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

3M

Investigadores

  • Investigador principal: Randall Coombs, MD, University of North Carolina, Chapel Hill
  • Investigador principal: Cedric Lefebvre, MD, Wake Forest University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2011

Finalización primaria (Actual)

1 de junio de 2012

Finalización del estudio (Actual)

1 de septiembre de 2012

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

24 de junio de 2011

Publicado por primera vez (Estimar)

27 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de junio de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

12 de junio de 2013

Última verificación

1 de junio de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 05-011427

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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