Suspended

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

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What is being tested

Unassisted vein visualization

+ Wee Sight® Transilluminator

+ VeinViewer® (Christie Digital Systems, Cypress, CA)

Procedure
Who is being recruted

Until 12 Months
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorUniversity of Nebraska
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

Official TitleNurse Peripheral Intravenous Catheter Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age
NCT01637987
Principal SponsorUniversity of Nebraska
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 12 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
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

7 exclusion criteria prevent from participating
PIV not required

Greater than 12 month birth date

PIV inserted by practitioner other than RN

PIV inserted by RN not employed by study areas

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Active Comparator
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.

Group III

Active Comparator
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Children's Hospital and Medical Center

Omaha, United StatesOpen Children's Hospital and Medical Center in Google Maps
SuspendedOne Study Center