VeinViewer for Peripheral IV Placement in Children With Difficult IV Access
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- First attempt IV success rates
Study Overview
Brief Summary
Hypothesis: The first attempt success rate for peripheral IV insertion for children with difficult IV access (difficult IV access [DIVA] score ≥ 4) by nurses using the VeinViewer guided technique is better than conventional method of IV placement.
Specific Aims:
- To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access
- To validate the DIVA score
Design: Prospective randomized controlled trial/Convenience sample
Subjects: Children (0-18) presenting to the emergency department who require an IV as determined by examining physician and with a DIVA score ≥ 3 during times when VeinViewer machine is available and a VeinViewer trained participating nurse is on duty.
Variables:
Outcome Variables: First IV attempt success rate
Predictor Variables: IV technique used, other potential modifiers (age, weight, height, skin shade, indication for IV, history of prematurity and, vein visibility/palpability after tourniquet)
Methods: Subjects who meet inclusion criteria will be randomized to either conventional IV technique or VeinViewer guided technique. The nurse will attempt the IV depending on the randomization. Success or failure on first IV attempt will be recorded. If unsuccessful, other attempts will be tried until a successful IV is placed or the physician decides to give an alternative therapy that does not need IV access.
Statistics: A chi square test will be used to compare the proportion of subjects with successful first attempt IV placement using the VeinViewer technique to that using the conventional method with 95% confidence interval. We, the researchers, will look at the median number of attempts to place an IV in each of the groups. Logistic regression will be performed to test for independent associations. Information collected during the study will also be used for validation of the DIVA score.
Risks: No extra risks are expected above that of receiving a standard IV. The standard risk of bleeding, bruising, pain, and infection will be possible regardless of technique used. The VeinViewer does not expose the patient the ionizing radiation. The use of the VeinViewer technique may increase the time need to place an IV in.
Potential Benefits: With this study, we, the researchers, hope to improve the success rate of children with difficult IV placement in the Emergency Department.
Detailed Description
Introduction:
Attempting to get peripheral intravenous (IV) access can be one of the most frustrating and irksome tasks medical professionals encounter. Many medical therapies require the placement of an IV. In an emergency situation, it can be the lifeline that makes the difference between a good or bad outcome. Determinants of successful IV placement include the skill and expertise of the person who places the IV, the veins of the person who receives the IV, and luck.
These difficulties are often magnified in children. Children have smaller veins. Children come in different sizes and shapes. Children are often uncooperative. Not uncommonly, multiple attempts at IV placement are required before success. The more attempts that are needed to get an IV placed, the more pain and anxiety a child experiences. Getting an IV in a timely manner can alter parental perceptions of the quality of care and improve parental satisfaction. Developing methods to improve success rate of IV placement has obvious benefits.
During a previous study, we were able to demonstrate that in 25% of the patients in our pediatric emergency department who have an IV placement attempt will fail the first IV attempt. We were able to develop a scoring system (termed DIVA score) that we believe will aid in identifying those more likely to have a failed first IV attempt and so therefore may more likely benefit from our intervention (VeinViewer™). By attempting to demonstrate improved success on those with an increase likelihood of failure on first IV attempt, we believe that we will decrease the number of subjects needed to show an effect and to limit this potentially resource intensive technique to those most likely to benefit.
The VeinViewer™ is an infrared imaging system that utilizes near-infrared light and other technologies to project a real-time image of the location and orientation (up to 0.06mm) of veins onto the surface of patient's skin. The VeinViewer™ received FDA clearance in August 2004 as a class I device. The VeinViewer's Infrared Light is considered harmless. We believe a potential application for the VeinViewer™ is to improve the success rate of IV insertion in
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presentation to the emergency department at Children's Hospital of Wisconsin (CHW)
- •0 to 19 years of age
- •Requires a peripheral IV as determined by the examining physician
- •DIVA score ≥ 3
- •During times when VeinViewer™ machine is available
- •During hours when a VeinViewer™ trained participating nurse is on duty
Exclusion Criteria
- •Central line available
- •Immunocompromised patient
- •Requirement for immediate IV placement (Patient's condition would potentially be compromised if there is a time delay in IV placement.)
Arms & Interventions
VeinViewer Arm
Attempts at IV placement will be made with use of the VeinViewer Machine
Intervention: VeinViewer (Device)
Conventional Method
IV attempted with conventional method
Outcomes
Primary Outcomes
First attempt IV success rates
Time Frame: Immediately after attempt
Secondary Outcomes
- Number of attempts required(Immediately after attempts)
Investigators
Kenneth Yen
Associate Professor of Pediatrics (Emergency Medicine) and Population Health (Epidemiology)
Medical College of Wisconsin