Nurse PIV Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Children's Hospital and Medical Center, Nebraska
Information provided by (Responsible Party):
Amy Phillips, Children's Hospital and Medical Center, Nebraska
ClinicalTrials.gov Identifier:
NCT01637987
First received: July 6, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods.


Condition Intervention
PIV Catheter Insertion
Vein Visualization
Procedure: Unassisted vein visualization
Procedure: Wee Sight® Transilluminator
Procedure: VeinViewer® (Christie Digital Systems, Cypress, CA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nurse Peripheral Intravenous Catheter Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Successful PIV insertion during first or second cannulation attempt. [ Time Frame: Immediate upon completing first or second PIV insertion attempt ] [ Designated as safety issue: No ]

    Success = Insertion of a 22 or 24-gauge catheter into a peripheral vein followed by the immediate ability to flush 1-2 ml normal saline without signs of venous infiltration (e.g., pain and swelling).

    Failure = Inability to insert a 22 or 24-gauge catheter into a peripheral vein, or insertion of a catheter into a peripheral vein followed by the immediate inability to flush 1-2 ml normal saline or signs of infiltration upon flushing.



Estimated Enrollment: 720
Study Start Date: July 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unassisted vein visualization Procedure: Unassisted vein visualization
The traditional technique of vein visualization and palpation will be used to identify veins during the PIV insertion procedures. This involves the use of a tourniquet to facilitate venous pooling to see the vein and prevent vein rupture during cannulation. Nurse may use heat application to facilitate vein identification.
Other Name: Traditional methods of vein identification
Active Comparator: Wee Sight Transilluminator Procedure: Wee Sight® Transilluminator
The Wee Sight® Transilluminator (Philips Children's Medical Ventures, Monroeville, PA) is a hand held, non-heat producing, light emitting diode (Class 2), battery operated device. The device is held adjacent to or under the subject's extremity to visualize the venous anatomy superficial veins absorb light and appear as dark lines against the surrounding illuminated tissues. Vein visualization improves with dimmed room lighting and a thin subcutaneous tissue layer. Nurse will assess vascular anatomy using traditional techniques of visualization and palpation with tourniquet/heat application as needed, and add the Wee Sight to assist in vein identification.
Other Name: Vein Transillumination
Active Comparator: Near Infra-red light (VeinViewer) Procedure: VeinViewer® (Christie Digital Systems, Cypress, CA)
VeinViewer near infrared light views hemoglobin up to 10 mm beneath skin. Hemoglobin absorbs the light while surrounding tissue scatters it providing a suitable contrast between the vein & surrounding subcutaneous tissue. This data is captured, digitally processed by video camera, and projected back onto the skin as a visual image of venous anatomy. Nurse will assess vascular anatomy using traditional techniques of visualization and palpation with tourniquet/heat application as needed, and add the VeinViewer to assist in vein identification.
Other Name: Vein Viewer

Detailed Description:

Obtaining peripheral intravenous (PIV) access is a nearly universal procedure for medical management of the hospitalized pediatric patient. In children, PIV placement can often be difficult due to the inability to identify peripheral veins (Wilson, 2007). Many assistive devices have been used or promoted to improve vein visualization with the intention of increasing PIV insertion success. Limited research was found to support this assumption regarding nursing PIV insertion success in children. This study is a randomized, controlled trial to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods. Patients admitted to Children's Hospital & Medical Center (CHMC) Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/ Intermediate Care Unit, up to 12 months of age requiring non-emergent PIV placement as part of their medical plan of care will be eligible. Following consent subjects will be randomized into one of three vein identification method study groups (1) Wee Sight Transilluminator - a hand held light emitting device held adjacent to or under the patient's extremity to visualize the venous anatomy; (2) VeinViewer - uses near infrared light to view hemoglobin and projects an image of venous anatomy onto the skin; and (3) Unassisted Methods - traditional techniques of vein visualization and palpation. Based on study group assignment the nurse will use the appropriate vein identification method during the first two PIV insertion attempts. Evaluation of vein identification methods will be based on PIV insertion success or failure.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to Children's Hospital & Medical Center Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/Intermediate Care Unit
  • Require non-emergent PIV placement as part of medical plan of care
  • Less than or equal to 12 month birth date

Exclusion Criteria:

  • Greater than 12 month birth date
  • PIV not required
  • PIV inserted by practitioner other than RN
  • PIV inserted by RN not employed by study areas
  • Ward of state
  • Require emergent PIV placement
  • Primary language is not English or Spanish
  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: NCT01637987

Locations
United States, Nebraska
Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68114
Sponsors and Collaborators
University of Nebraska
Children's Hospital and Medical Center, Nebraska
Investigators
Principal Investigator: Kimberly A Peterson, MSN Children's Hospital and Medical Center, Omaha, NE
  More Information

Publications:
Responsible Party: Amy Phillips, Clinical Nurse Specialist, Children's Hospital and Medical Center, Nebraska
ClinicalTrials.gov Identifier: NCT01637987     History of Changes
Other Study ID Numbers: 694-11-EP
Study First Received: July 6, 2012
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of Nebraska:
Peripheral intravenous catheter
Vein visualization
Transillumination
Near infrared light

ClinicalTrials.gov processed this record on August 19, 2014