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CompletedNCT00935909Updated Jun 21, 2013

Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access

An observational study in IV Cannulation, sponsored by Peter Szmuk. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by Peter Szmuk · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
603
Ages
Up to 18 Years
Sex
All
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Study summary

The primary purpose of this prospective, randomized trial is successful intravenous (IV) cannulation on first attempt with the use of either the Vein Viewer (VV) or standard cannulation method. The secondary purpose is to find out if there is a difference in the total time to successful cannulation.

Read the detailed description

A single initial data page will be filled out by one of the study team members present with the IV Team at the time of the cannulation. The data from these forms will be entered by the investigator or research assistant into a database maintained only for this study. There will be two groups in this randomized study. One group will receive IV cannulation with the VV and the second group will receive standard cannulation without the VV. The chance of receiving either treatment is based on randomly generated computer codes, unknown by the IV team. We want to evaluate successful IV cannulation on first attempt as well as the time taken for cannulation. All documents will be de-identified of data that contains HIPAA protected health information (PHI) at the end of the study. We estimate approximate enrollment to be 790 children. The study is expected to last 12 months and will only be conducted at Children's Medical Center Dallas.

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Conditions studied

  • IV Cannulation

Keywords

  • IV cannulation
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In context

Lead sponsor

This is the only study on the registry with Peter Szmuk as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The floor patients meeting the inclusion/exclusion criteria that need an IV

Inclusion criteria

  • Patients age 0-18 requiring IV cannula (ASA 1-4) with a modified DIVA score ≥ 2 at the time of assessment

Exclusion criteria

Exclusion Criteria:

  • Patients with visible veins will be excluded from the study as well as patients with known difficult IV access which are scheduled for PICC line placement.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
603 participants (actual)
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What researchers measure

Primary outcomes

  1. Successful IV cannulation on the first attempt

    Time frame: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.

Secondary outcomes

  1. Total time to successful IV cannulation

    Time frame: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.

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Study locations

1 site
  • Children's Medical Center Dallas
    Dallas, Texas 75235, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00935909
Lead sponsor
Peter Szmuk
Collaborators
Luminex Corporation, Outcomes Research Consortium
Responsible party
Peter Szmuk (Professor, University of Texas Southwestern Medical Center) — Sponsor-investigator
First posted
Jul 9, 2009
Start date
Jan 2009
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Jun 21, 2013

Study contacts

Peter Szmuk, MD
principal investigator · UT Southwestern

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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