NCT00357799

Brief Summary

Hypothesis: The first attempt success rate for peripheral IV insertion for children with difficult IV access (difficult IV access \[DIVA\] score ≥ 4) by nurses using the VeinViewer guided technique is better than conventional method of IV placement. Specific Aims:

  1. 1.To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access
  2. 2.To validate the DIVA score

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 24, 2011

Status Verified

August 1, 2011

Enrollment Period

4 years

First QC Date

July 26, 2006

Last Update Submit

August 22, 2011

Conditions

Catheterization, PeripheralPhlebotomy

Keywords

VenipunctureRandomized Controlled TrialIntravenous AccessChildrenEmergency Department NursingVeinViewerPediatricsEmergency Nursing

Outcome Measures

Primary Outcomes (1)

  • First attempt IV success rates

    Immediately after attempt

Secondary Outcomes (1)

  • Number of attempts required

    Immediately after attempts

Study Arms (2)

VeinViewer Arm

ACTIVE COMPARATOR

Attempts at IV placement will be made with use of the VeinViewer Machine

Device: VeinViewer

Conventional Method

NO INTERVENTION

IV attempted with conventional method

Interventions

VeinViewerDEVICE

Using the VeinViewer, IV attempts will be made

VeinViewer Arm

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Presentation to the emergency department at Children's Hospital of Wisconsin (CHW)
  • to 19 years of age
  • Requires a peripheral IV as determined by the examining physician
  • DIVA score ≥ 3
  • During times when VeinViewer™ machine is available
  • During hours when a VeinViewer™ trained participating nurse is on duty

You may not qualify if:

  • Central line available
  • Immunocompromised patient
  • Requirement for immediate IV placement (Patient's condition would potentially be compromised if there is a time delay in IV placement.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin Emergency Department and Trauma Center

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (4)

  • Yen K, Gorelick MH. Ultrasound applications for the pediatric emergency department: a review of the current literature. Pediatr Emerg Care. 2002 Jun;18(3):226-34. doi: 10.1097/00006565-200206000-00020. No abstract available.

    PMID: 12066016BACKGROUND

  • Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.

    PMID: 18347490BACKGROUND

  • Abel WM, Efird JT, Crane PB, Ferdinand KC, Foy CG, DeHaven MJ. Use of coaching and technology to improve blood pressure control in Black women with hypertension: Pilot randomized controlled trial study. J Clin Hypertens (Greenwich). 2023 Jan;25(1):95-105. doi: 10.1111/jch.14617. Epub 2022 Dec 20.

    PMID: 36537265DERIVED

  • Abel WM, Spikes T, Greer DB. A Qualitative Study: Hypertension Stigma Among Black Women. J Cardiovasc Nurs. 2021 Mar-Apr 01;36(2):96-103. doi: 10.1097/JCN.0000000000000759.

    PMID: 33148961DERIVED

Study Officials

  • Kenneth Yen, MD MS

    Medical College of WIsconsin and Children's Research Institute

    PRINCIPAL INVESTIGATOR

  • Anne Riegert, RN

    Children Hospital of Wisconsin Health Systems

    PRINCIPAL INVESTIGATOR

  • Marc H Gorelick, MD MSCE

    Medical College of Wisconsin and Children's Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics (Emergency Medicine) and Population Health (Epidemiology)

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 28, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 24, 2011

Record last verified: 2011-08

Locations

US(1)