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VeinViewer Assisted Intravenous Catheter Placement in the Pediatric Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468065
Recruitment Status : Unknown
Verified April 2007 by Lifespan.
Recruitment status was:  Recruiting
First Posted : May 1, 2007
Last Update Posted : May 7, 2008
Information provided by:

Brief Summary:
The objective of this study is to evaluate the effectiveness of the VeinViewer® near infrared device to facilitate the placement of intravenous catheters in children who require intravenous cannulation in the pediatric emergency department. This clinical protocol is designed to determine whether using the VeinViewer increases the ease and efficiency of IV cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks and extravasations, and decreases the child's and the parents perception of the pain of IV cannulation.

Condition or disease Intervention/treatment Phase
Catheterization Device: VeinViewer Device: Veinviewer Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VeinViewer Assisted Intravenous Catheter Placement in the Pediatric Emergency Department
Study Start Date : April 2007
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: A
TO use Veinviewer to improve the effectiveness of IV starts in children
Device: VeinViewer
Veinveiwer is used to view veins subQ

Device: Veinviewer
near infrared light reveals veins subcutaneously

No Intervention: B
Standard approach to placing IV s in children

Primary Outcome Measures :
  1. Time to successful placement of IV by practitioner [ Time Frame: one hour ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must be children between the ages of 8-17 who present to the pediatric emergency department and require intravenous cannulation as part of their regular care
  • Both the child and the parent/guardian must be English-speaking
  • Both the child and the parent/guardian must be comfortable with the experimental protocol as explained to them by the study investigator or a research assistant
  • The parent/guardian must be able to understand and sign informed consent and a HIPAA form
  • The child must provide assent
  • The child must demonstrate understanding of the 100mm standard Visual Analog Scale

Exclusion Criteria:

Participants must not have:

  • Need for an emergent IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468065

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Contact: Bruce M Becker, MD 401-444-6654
Contact: Laura Chapman Chapman, MD 401-444-6654

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United States, Rhode Island
Hasbro Children's Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Bruce M Becker, MD    401-444-6654   
Sponsors and Collaborators
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Principal Investigator: Bruce M Becker Lifespan
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bruce Becker, Lifespan Identifier: NCT00468065    
Other Study ID Numbers: 0037-07
First Posted: May 1, 2007    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: April 2007
Keywords provided by Lifespan:
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes