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OpenTrials
Completed

NCT Number: NCT00935909

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

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.

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Key information

Conditions

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Peter Szmuk

Other

Collaborators

  • Luminex Corporation
  • Outcomes Research Consortium

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2009
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.