Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access
Recruitment status was Recruiting
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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. |
- 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 ]
- 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 ]
| Estimated Enrollment: | 790 |
| Study Start Date: | January 2009 |
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 |
The floor patients meeting the inclusion/exclusion criteria that need an IV
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| Contact: Peter Szmuk, MD | 214-456-6404 | peter.szmuk@utsouthwestern.edu |
| United States, Texas | |
| Children's Medical Center Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Peter Szmuk, MD 214-456-6404 peter.szmuk@utsouthwestern.edu | |
| Principal Investigator: Peter Szmuk, MD | |
| Sub-Investigator: Lynnell Daniel, MD | |
| Sub-Investigator: Melissa Whitehead, RN | |
| Principal Investigator: | Peter Szmuk, MD | UT Southwestern |
More Information
No publications provided
| Responsible Party: | Peter Szmuk, MD, UTSouthwestern Medical Center and Children's Medical Center Dallas |
| ClinicalTrials.gov Identifier: | NCT00935909 History of Changes |
| Other Study ID Numbers: | 112008-014 |
| Study First Received: | July 2, 2009 |
| Last Updated: | July 8, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
IV cannulation |
ClinicalTrials.gov processed this record on May 19, 2013