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Clinical Trials/NCT01637987
NCT01637987
Terminated
Not Applicable

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

University of Nebraska1 site in 1 country104 target enrollmentJuly 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PIV Catheter Insertion
Sponsor
University of Nebraska
Enrollment
104
Locations
1
Primary Endpoint
Successful PIV insertion during first or second cannulation attempt.
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2012
End Date
February 2, 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Successful PIV insertion during first or second cannulation attempt.

Time Frame: Immediate upon completing first or second PIV insertion attempt

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.

Study Sites (1)

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