Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access
This study has been completed.
Outcomes Research Consortium
Information provided by (Responsible Party):
Peter Szmuk, University of Texas Southwestern Medical Center
First received: July 2, 2009
Last updated: June 19, 2013
Last verified: June 2013
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access.
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||up to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The floor patients meeting the inclusion/exclusion criteria that need an IV
- Patients age 0-18 requiring IV cannula (ASA 1-4) with a modified DIVA score ≥ 2 at the time of assessment
- 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00935909
|Children's Medical Center Dallas
|Dallas, Texas, United States, 75235 |
Outcomes Research Consortium
||Peter Szmuk, MD
No publications provided
||Peter Szmuk, Professor, University of Texas Southwestern Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 2, 2009
||June 19, 2013
||United States: Institutional Review Board
Keywords provided by University of Texas Southwestern Medical Center:
ClinicalTrials.gov processed this record on August 03, 2015