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

Completed · Phase 2/Phase 3

Conditions studied: Catheterization, Peripheral, Phlebotomy

In brief

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: 1. To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access 2. 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.

Key facts

Study ID

NCT00357799

Run by

Children's Hospital and Health System Foundation, Wisconsin

People needed

170

Starts

2006-10-01

Expected to finish

2010-10-01

Last updated by the study team

2011-08-24

Who can join

Age: any, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Children's Hospital of Wisconsin Emergency Department and Trauma Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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