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

This study has been completed.
Sponsor:
Collaborators:
Luminex Corporation
Outcomes Research Consortium
Information provided by (Responsible Party):
Peter Szmuk, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00935909
First received: July 2, 2009
Last updated: June 19, 2013
Last verified: June 2013

July 2, 2009
June 19, 2013
January 2009
July 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00935909 on ClinicalTrials.gov Archive Site
Total time to successful IV cannulation [ Time Frame: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation. ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

IV Cannulation
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
603
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00935909
112008-014
No
Peter Szmuk, University of Texas Southwestern Medical Center
Peter Szmuk
  • Luminex Corporation
  • Outcomes Research Consortium
Principal Investigator: Peter Szmuk, MD UT Southwestern
University of Texas Southwestern Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP