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Clinical Trials/NCT00935909
NCT00935909
Completed
Not Applicable

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

Peter Szmuk1 site in 1 country603 target enrollmentJanuary 2009
ConditionsIV Cannulation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
IV Cannulation
Sponsor
Peter Szmuk
Enrollment
603
Locations
1
Primary Endpoint
Successful IV cannulation on the first attempt
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
July 2010
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Peter Szmuk
Responsible Party
Sponsor Investigator
Principal Investigator

Peter Szmuk

Professor

University of Texas Southwestern Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Total time to successful IV cannulation(Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.)

Study Sites (1)

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