Nurse PIV Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age
|ClinicalTrials.gov Identifier: NCT01637987|
Recruitment Status : Terminated (Combination of insufficient research staff support, insufficient subjects meeting enrollment criteria, and investigators changing role responsibilities.)
First Posted : July 11, 2012
Last Update Posted : October 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|PIV Catheter Insertion Vein Visualization||Procedure: Unassisted vein visualization Procedure: Wee Sight® Transilluminator Procedure: VeinViewer® (Christie Digital Systems, Cypress, CA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nurse Peripheral Intravenous Catheter Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
|Active Comparator: Unassisted vein visualization||
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 Name: Traditional methods of vein identification
|Active Comparator: Wee Sight Transilluminator||
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 Name: Vein Transillumination
|Active Comparator: Near Infra-red light (VeinViewer)||
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 Name: Vein Viewer
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637987
|United States, Nebraska|
|Children's Hospital and Medical Center|
|Omaha, Nebraska, United States, 68114|
|Principal Investigator:||Kimberly A Peterson, MSN||Children's Hospital and Medical Center, Omaha, NE|