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

NCT01637987 | Terminated

• 1 other identifier: 0694-11-EP
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

PIV Catheter Insertion; Vein Visualization

Keywords

Peripheral intravenous catheter; Vein visualization; Transillumination; Near infrared light

Outcome Measures

Primary Outcomes (1)

• Successful PIV insertion during first or second cannulation 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

Study Arms (3)

Unassisted vein visualization

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.

Procedure: Unassisted vein visualization

Wee Sight Transilluminator

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.

Procedure: Wee Sight® Transilluminator

Near Infra-red light (VeinViewer)

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.

Procedure: VeinViewer® (Christie Digital Systems, Cypress, CA)

Interventions

Unassisted vein visualization 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.

Also known as: Traditional methods of vein identification

Unassisted vein visualization

Wee Sight® Transilluminator 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.

Also known as: Vein Transillumination

Wee Sight Transilluminator

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

Also known as: Vein Viewer

Near Infra-red light (VeinViewer)

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Children's Hospital and Medical Center, Omaha, Nebraska: collaborator

Study Sites (1)

Children's Hospital and Medical Center

Omaha, Nebraska, 68114, United States

Location

Related Publications (4)

• Peterson KA, Phillips AL, Truemper E, Agrawal S. Does the use of an assistive device by nurses impact peripheral intravenous catheter insertion success in children? J Pediatr Nurs. 2012 Apr;27(2):134-43. doi: 10.1016/j.pedn.2010.10.009. Epub 2011 Feb 18.

  PMID: 22341192 BACKGROUND

• Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.

  PMID: 21854488 BACKGROUND

• Perry AM, Caviness AC, Hsu DC. Efficacy of a near-infrared light device in pediatric intravenous cannulation: a randomized controlled trial. Pediatr Emerg Care. 2011 Jan;27(1):5-10. doi: 10.1097/PEC.0b013e3182037caf.

  PMID: 21178814 BACKGROUND

• Hess HA. A biomedical device to improve pediatric vascular access success. Pediatr Nurs. 2010 Sep-Oct;36(5):259-63.

  PMID: 21067078 BACKGROUND

Study Officials

• Kimberly A Peterson, MSN

  Children's Hospital and Medical Center, Omaha, NE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 11, 2012
• Study Start: July 1, 2012
• Primary Completion: February 2, 2017
• Study Completion: February 2, 2017
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

US (1)