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Sponsors and Collaborators: |
Children's Hospital and Health System Foundation, Wisconsin American Academy of Pediatrics |
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Information provided by: | Children's Hospital and Health System Foundation, Wisconsin |
ClinicalTrials.gov Identifier: | NCT00357799 |
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:
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 ≥ 4 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.
Condition | Intervention | Phase |
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Catheterization, Peripheral Phlebotomy |
Device: VeinViewer |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | VeinViewer for Peripheral IV Placement in Children With Difficult IV Access |
Estimated Enrollment: | 170 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
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VeinViewer Arm: Active Comparator
Attempts at IV placement will be made with use of the VeinViewer Machine
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Device: VeinViewer
Using the VeinViewer, IV attempts will be made
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Ages Eligible for Study: | up to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenneth Yen, MD MS | 414-266-3190 | kyen@mcw.edu |
Contact: Duke Wagner | 414-266-2623 | dwagner@mcw.edu |
United States, Wisconsin | |
Children's Hospital of Wisconsin Emergency Department and Trauma Center | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Kenneth Yen, MD MS 414-266-3190 kyen@mcw.edu | |
Contact: Duke Wagner, DC CCRC 414-266-2623 dwagner@mcw.edu | |
Principal Investigator: Kenneth Yen, MD MSCE | |
Sub-Investigator: Anne Riegert, RN | |
Principal Investigator: Marc H Gorelick, MD MSCE |
Principal Investigator: | Kenneth Yen, MD MS | Medical College of WIsconsin and Children's Research Institute |
Principal Investigator: | Anne Riegert, RN | Children Hospital of Wisconsin Health Systems |
Principal Investigator: | Marc H Gorelick, MD MSCE | Medical College of Wisconsin and Children's Research Institute |
Study ID Numbers: | CHW 06/139, GC 185 |
Study First Received: | July 26, 2006 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00357799 |
Health Authority: | United States: Institutional Review Board |
Venipuncture Randomized Controlled Trial Intravenous Access Children |
Emergency Department Nursing VeinViewer Pediatrics Emergency Nursing |
Emergencies |