VeinViewer Assisted Intravenous Catheter Placement in the Pediatric Emergency Department

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Lifespan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lifespan
ClinicalTrials.gov Identifier:
NCT00468065
First received: April 27, 2007
Last updated: May 5, 2008
Last verified: April 2007
  Purpose

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 Intervention Phase
Catheterization
Device: VeinViewer
Device: Veinviewer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VeinViewer Assisted Intravenous Catheter Placement in the Pediatric Emergency Department

Further study details as provided by Lifespan:

Primary Outcome Measures:
  • Time to successful placement of IV by practitioner [ Time Frame: one hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468065

Contacts
Contact: Bruce M Becker, MD 401-444-6654 bbecker@lifespan.org
Contact: Laura Chapman Chapman, MD 401-444-6654 bbecker@lifespan.org

Locations
United States, Rhode Island
Hasbro Children's Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Bruce M Becker, MD    401-444-6654    bbecker@lifespan.org   
Sponsors and Collaborators
Lifespan
Investigators
Principal Investigator: Bruce M Becker Lifespan
  More Information

No publications provided by Lifespan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruce Becker, Lifespan
ClinicalTrials.gov Identifier: NCT00468065     History of Changes
Other Study ID Numbers: 0037-07
Study First Received: April 27, 2007
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Lifespan:
intravenous
catheter
IV

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014