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

NCT ID: NCT00935909

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

603 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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IV Cannulation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luminex Corporation

INDUSTRY

Sponsor Role collaborator

Outcomes Research Consortium

OTHER

Sponsor Role collaborator

Peter Szmuk

OTHER

Sponsor Role lead

Responsible Party

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Peter Szmuk

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peter Szmuk, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

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Children's Medical Center Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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112008-014

Identifier Type: -

Identifier Source: org_study_id

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