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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2017-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

VeinViewer for Peripheral IV Placement in Children With Difficult Intravenous (IV) Access

NCT00357799

Catheterization, Peripheral Phlebotomy

COMPLETED PHASE2/PHASE3

Use of Ultrasound Guidance to Facilitate Obtaining Peripheral Intravenous Access

NCT04877301

Catheterization, Peripheral

WITHDRAWN NA

Image Guidance for Improved Vessel Cannulation in Pediatric Patients

NCT04031495

Central Vein Cannulation

COMPLETED NA

Ultrasound Assisted Peripheral Venous Access in Young Children

NCT00557154

Catheterization, Peripheral

COMPLETED NA

Near Infrared Light in Paediatric Blood Drawing Centre

NCT03277092

Blood Drawing Procedure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PIV Catheter Insertion Vein Visualization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Unassisted vein visualization

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Wee Sight® Transilluminator

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

VeinViewer® (Christie Digital Systems, Cypress, CA)

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Traditional methods of vein identification Vein Transillumination Vein Viewer

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No