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

December 29, 2023 updated by: University of Nebraska

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Children's Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Unassisted vein visualization
The traditional technique of vein visualization and palpation will be used to identify veins during peripheral intravenous line (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.
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 Names:
  • Traditional methods of vein identification
Active Comparator: 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 assists in vein identification by being 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. This will be used to identify veins during peripheral intravenous line (PIV) insertion procedures.
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 Names:
  • Vein Transillumination
Active Comparator: Near Infra-red light (VeinViewer)
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. This will be used to identify veins during peripheral intravenous line (PIV) insertion procedures.
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 Names:
  • Vein Viewer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediate upon completing first or second PIV insertion attempt

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Children's Hospital and Medical Center, Omaha, Nebraska

Investigators

  • Principal Investigator: Kimberly A Peterson, MSN, Children's Hospital and Medical Center, Omaha, NE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

February 2, 2017

Study Completion (Actual)

February 2, 2017

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimated)

July 11, 2012

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0694-11-EP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PIV Catheter Insertion

Clinical Trials on Unassisted vein visualization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe