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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
  Purpose

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.


Condition
IV Cannulation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access.

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 603
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935909

Locations
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Peter Szmuk
Luminex Corporation
Outcomes Research Consortium
Investigators
Principal Investigator: Peter Szmuk, MD UT Southwestern
  More Information

No publications provided

Responsible Party: Peter Szmuk, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00935909     History of Changes
Other Study ID Numbers: 112008-014
Study First Received: July 2, 2009
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
IV cannulation

ClinicalTrials.gov processed this record on November 25, 2014