Recruiting

VeinViewer

Sponsor:

Lifespan

Code:

NCT00468065

Conditions

Catheterization

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

VeinViewer

Veinviewer

Study Details

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.

Conditions

Catheterization

Study ID

NCT00468065

Start date

Apr, 2007

Status verified date

Apr, 2007

Completion date

Dec, 2008

Anticipated

Primary completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

TO use Veinviewer to improve the effectiveness of IV starts in children

no intervention: B

Standard approach to placing IV s in children

Interventions

VeinViewer

Veinveiwer is used to view veins subQ

Veinviewer

near infrared light reveals veins subcutaneously

Primary outcome measure

  • Time to successful placement of IV by practitioner [ Time Frame: one hour ]

Central Contacts and Locations

Central contacts

Bruce M Becker, MD

401-444-6654bbecker@lifespan.org

Laura Chapman Chapman, MD

401-444-6654bbecker@lifespan.org

Locations

Hasbro Children's Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Bruce M Becker, MD

401-444-6654bbecker@lifespan.org

More Information

Sponsor

Lifespan

Last update posted

May 7, 2008

Last verified

Apr, 2007

Keywords

  • intravenous
  • catheter
  • IV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Lifespan on 2008-05-07.