VeinViewer Assisted Intravenous Catheter Placement in the Pediatric Emergency Department
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 27, 2007
CompletedFirst Posted
Study publicly available on registry
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMay 7, 2008
April 1, 2007
1.7 years
April 27, 2007
May 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to successful placement of IV by practitioner
one hour
Study Arms (2)
A
EXPERIMENTALTO use Veinviewer to improve the effectiveness of IV starts in children
B
NO INTERVENTIONStandard approach to placing IV s in children
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participants must not have:
- Need for an emergent IV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lifespanlead
Study Sites (1)
Hasbro Children's Hospital
Providence, Rhode Island, 02903, United States
Related Publications (1)
Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.
PMID: 21854488DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce M Becker
Lifespan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 27, 2007
First Posted
May 1, 2007
Study Start
April 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
May 7, 2008
Record last verified: 2007-04