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VeinViewer for Peripheral IV Placement in Children With Difficult Intravenous (IV) Access
NCT00357799 · View on ClinicalTrials.gov ↗
Study 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: 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 stand
Conditions Studied
Interventions
- DEVICE VeinViewer
Study Locations (1)
Wisconsin
- Children's Hospital of Wisconsin Emergency Department and Trauma Center — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2006-10 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00357799
The ClinicalTrials.gov registry entry for NCT00357799 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital and Health System Foundation, Wisconsin, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Catheterization, Peripheral appearing as the primary indexed condition, and to 1 intervention — of which VeinViewer is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00357799 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00357799 about?
NCT00357799 is a clinical study titled "VeinViewer for Peripheral IV Placement in Children With Difficult Intravenous (IV) Access". 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 V...
What is the current status of trial NCT00357799?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2006-10. Estimated completion is 2010-10.
What conditions does trial NCT00357799 study?
This clinical trial studies the following conditions: Catheterization, Peripheral, Phlebotomy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00357799?
The interventions under investigation include: VeinViewer (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00357799?
This trial is sponsored by Children's Hospital and Health System Foundation, Wisconsin, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00357799 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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