Catheterization Clinical Trial
Official title:
VeinViewer Assisted Intravenous Catheter Placement in the Pediatric Emergency Department
The objective of this study is to evaluate the effectiveness of the VeinViewer® near infrared device to facilitate the placement of intravenous catheters in children who require intravenous cannulation in the pediatric emergency department. This clinical protocol is designed to determine whether using the VeinViewer increases the ease and efficiency of IV cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks and extravasations, and decreases the child's and the parents perception of the pain of IV cannulation.
Needle sticks are part of many standard treatments in the pediatric emergency department
(ED) and are frequently a source of pain and anxiety for children. Intravenous catheters
(IVs) have been shown to be among the leading causes of pain in hospitalized children 1 and
venipucture is commonly seen as one of the most painful and frequently performed invasive
procedures by nurses. 2 (Jacobson et al.) Children recording VAS pain scores in response to
IV catheter placement in the Emergency Department rated the pain as 3.23/5.0 and their
parent rated their children's pain as 3.4/5.0. 3 (Skarbek et al.) The placement of
intravenous catheters would be more efficient and less stressful if the clinician had a
clear roadmap or picture highlighting the location of the vein. The lack a clear visual
guide to IV placement often leads to multiple painful attempts at catheter placement as well
as delays urgent in treatment ( I.V. fluid and medication administration) and increased use
of human resources. The current average number of catheter punctures needed in order to
achieve successful catheter placement is 2.4 with a range of 1-14. 4 ( Larue, GD ) The
VeinViewer by Luminetx⢠allows the clinician to clearly see the child's accessible
vasculature or the lack thereof in real time, directly on the surface of the skin. The
clinician can be trained to operate the VeinViewer in minutes and use does not require any
additional job or skills certification. The VeinViewer is free standing and hands-free
allowing the clinician the freedom to use both hands to carry out the work of placing the
catheter (unlike ultrasound which requires one hand to hold the probe and the other hand to
place the catheter, unless two people are available and able to coordinate their work
efforts thus doubling the resources necessary for I.V. placement. The VeinViewer is
non-invasive and causes no tissue damage. There is no patient contact with the device and
therefore no risk of infectious disease contamination with blood products. The VeinViewer
uses near-infrared light to locate subcutaneous veins and project their location onto the
surface of the skin thus creating a visible roadmap for I.V catheter placement. This
protocol describes a prospective, randomized, study, evaluating the effectiveness of
VeinViewer in increasing the ease of intravenous cannulation in children receiving
intravenous cannulation in the pediatric emergency department. The investigators hypothesize
that cannulation using VeinViewerâ will require fewer sticks and will result in fewer missed
or repeated IV starts, fewer extravasating ("blown vein") IV placements, increased perceived
ease of placement by the operator, and decreased pain associated with the IV placement as
perceived by the child, the parent, and the operator.
2. Background Intravenous cannulation is a routine and common part of treatment for children
receiving care in the Pediatric Emergency Department. Intravenous cannulation is painful and
often challenging in children. Peripheral IV's are generally placed using visual and/or
tactile cues. These may be minimal or deceptive in children who often have small peripheral
veins and increased subcutaneous fat with opaque, elastic skin. Health care workers often
struggle to place these IV's successfully making multiple sticks, infiltrating subcutaneous
tissues, requiring extensive operator time, and, most importantly, causing the patient and
the parent distress. A number of approaches have been tried, attempting to decrease the pain
of these cannulations. Most of these involve the cutaneous application of lidocaine in an
attempt to numb the skin and decrease the pain of the stick.
EMLA and more recently, LMX (lidocaine in liposomal delivery system) are effective topical
agents but there is a 30 minute dwell time - inappropriate in the Emergency Medicine
setting. A number of devices have been tested which decrease the barrier of the stratum
corneum thus allowing the lidocaine to anesthetize the skin in 3-5 minutes. These include a
hand held laser (effective but burns and pigments the skin), a small ultrasound (effective
but bulky and difficult to use), and gas pressure driven powdered lidocaine (effective but
not approved by the FDA yet for general sales and distribution). These devices depend on
identifying the vein and then successfully cannulating the identified vein through the
anestethized skin. Missed sticks force the operator to begin the anesthesia process all over
again in a different site. This process is time consuming and ineffective in the ED setting.
Other centers have begun to employ ultrasound to identify the veins for peripheral
cannulation to cannulate under indirect visualization. This process is difficult for small
mobile pediatric veins and requires extensive operator training and practice. It also
requires an extra set of operator hands when children, often less than cooperative, are
involved. It is unclear that this approach will be effective in the Pediatric ED.
Vein Viewerâ is a hands off device that projects a map of the subcutaneous veins onto the
surface of the skin. It allows the operator to insert the IV catheter under direct
visualization. It can be used by one operator who can insert the catheter and restrain the
child's arm while using the device. Direct visualization is accurate and decreases the blind
sticks, missed "fishing expeditions", and extravasations of IV fluid and medication (often
not benign) that can occur with IV cannulation, especially in children. Decreasing the
number of sticks and the time to successful catheterization will decrease the child's and
the parents perceived pain of the procedure and the operator time to effective
catheterization thus increasing the efficiency of the operator and the ED in general, and
speeding the initiation of therapy (IV hydration or medication). The Vein Viewer has no side
effects and is visually interesting to children and parents. It has the potential to
revolutionize the effectiveness and efficiency, of IV cannulation in the Pediatric Emergency
Department and decrease substantially the child's and the parent's perceived pain from the
procedure and fear of the procedure.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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