NCT00468065

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 7, 2008

Status Verified

April 1, 2007

Enrollment Period

1.7 years

First QC Date

April 27, 2007

Last Update Submit

May 5, 2008

Conditions

Keywords

intravenouscatheterIV

Outcome Measures

Primary Outcomes (1)

  • Time to successful placement of IV by practitioner

    one hour

Study Arms (2)

A

EXPERIMENTAL

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

Device: VeinViewer

B

NO INTERVENTION

Standard approach to placing IV s in children

Interventions

Veinveiwer is used to view veins subQ

A

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

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.

Study Officials

  • Bruce M Becker

    Lifespan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce M Becker, MD

CONTACT

Laura Chapman Chapman, MD

CONTACT

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

Locations