2 Clinical Trials for Various Conditions
The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. Secondary objectives include determining whether ultrasound-guided IV access lowers the overall number of IV attempts and/or reduces time to IV access. The investigators will also examine the duration of IV access and any complications related to IV access in both the traditional and ultrasound guided IV access group.
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.