NCT01133652

Brief Summary

Children fear having an intravenous (IV) needle placed because of the pain that they will experience. The more needle punctures that a child has to endure before the IV is successfully placed, the greater the pain experienced and anxiety suffered. In addition, false starts increase the demands on medical staff and can increase the length of the emergency department stay. Often, veins are difficult to see or feel, particularly in an unwell, dehydrated child or in young infants who have more fat below the skin surface. Also, the venous pattern below the skin surface naturally varies from person to person and therefore success in placing IVs leaves room for improvement. Technology may be able to play an important role is improving the rates of success. The investigators wish to investigate whether the use of either an Ultrasound machine or a VeinViewer machine can improve the rate of success of the initial attempt (skin puncture) at peripheral IV placement in comparison to the current standard approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
399

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2010

Typical duration for phase_4

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

Study Start

First participant enrolled

May 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

May 18, 2010

Last Update Submit

August 23, 2012

Conditions

CatheterizationPeripheral Phlebotomy

Keywords

VenipunctureRandomized Controlled TrialIntravenous accessChildrenPediatric Emergency DepartmentPeripheral intravenous catheterizationCatheterization, Peripheral Phlebotomy

Outcome Measures

Primary Outcomes (1)

  • Success or failure of peripheral IV placement on first attempt.

    The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.

    Within one hour of start of procedure

Secondary Outcomes (2)

  • Number of attempts to successful IV placement

    Within one hour of start of procedure

  • Time to successful placement of IV

    Within one hour

Study Arms (3)

VeinViewer

ACTIVE COMPARATOR

The Veinviewer machine will be used to guide intravenous access.

Device: Veinviewer

Ultrasound

ACTIVE COMPARATOR

The Ultrasound will be used to guide intravenous access.

Device: Ultrasound

Conventional IV placement

ACTIVE COMPARATOR

IV will be placed using conventional technique

Other: Conventional technique

Interventions

VeinviewerDEVICE

Veinviewer machine

VeinViewer
UltrasoundDEVICE

Ultrasound

Ultrasound
Conventional techniqueOTHER

Conventional IV placement by nurses

Conventional IV placement

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 0-16 presenting to the Pediatric Emergency Department (PED)
  • Require IV as part of routine care
  • Knowledge of English language

You may not qualify if:

  • Child in critical condition
  • Child requires urgent IV placement
  • Central line available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital Pediatric Emergency Department

Edmonton, Alberta, T6G 2 J3, Canada

Location

Related Publications (1)

  • Curtis SJ, Craig WR, Logue E, Vandermeer B, Hanson A, Klassen T. Ultrasound or near-infrared vascular imaging to guide peripheral intravenous catheterization in children: a pragmatic randomized controlled trial. CMAJ. 2015 May 19;187(8):563-570. doi: 10.1503/cmaj.141012. Epub 2015 Apr 20.

    PMID: 25897047DERIVED

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Sarah J Curtis, MD

    Division of Pediatric Emergency Medicine, Department of Pediatrics & Women and Children's Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sarah Curtis

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 31, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

CA(1)