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Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques (VISION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Curtis, University of Alberta
ClinicalTrials.gov Identifier:
NCT01133652
First received: May 18, 2010
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Catheterization
Peripheral Phlebotomy
 Device: Veinviewer
Device: Ultrasound
Other: Conventional technique
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The VISION STUDY: Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Success or failure of peripheral IV placement on first attempt. [ Time Frame: Within one hour of start of procedure ] [ Designated as safety issue: No ]
    The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.


Secondary Outcome Measures:
  • Number of attempts to successful IV placement [ Time Frame: Within one hour of start of procedure ] [ Designated as safety issue: No ]
    The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.

  • Time to successful placement of IV [ Time Frame: Within one hour ] [ Designated as safety issue: No ]
    The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.


Enrollment: 399
Study Start Date: May 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VeinViewer
The Veinviewer machine will be used to guide intravenous access.
 Device: Veinviewer
Veinviewer machine
Other Name: VeinViewer
Active Comparator: Ultrasound
The Ultrasound will be used to guide intravenous access.
 Device: Ultrasound
Ultrasound
Other Name: Ultrasound
Active Comparator: Conventional IV placement
IV will be placed using conventional technique
 Other: Conventional technique
Conventional IV placement by nurses
Other Name: Conventional technique

Detailed Description:

Peripheral IV line placement is one of the most common and challenging painful procedures performed in the pediatric emergency department (PED). The lack of a clear visual guide for IV placement often leads to multiple painful attempts; delays in urgent treatment; increased use of human resources; increased costs; and increased anxiety in the patient, the parents and the staff. The research plan is a randomized controlled trial (RCT) to compare the use of two new technologies with the current standard method for vein location and IV placement in children.We would like to know if either of these technologies improve rates of successful IV placement on first attempt. Furthermore we would like to know if either technology leads to decreased time spent by staff on the procedure or decreased overall number of painful attempts. Information on nursing satisfaction, parental satisfaction and cost analysis will also be obtained.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Child in critical condition
  • Child requires urgent IV placement
  • Central line available
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133652

Locations
Canada, Alberta
Stollery Children's Hospital Pediatric Emergency Department
Edmonton, Alberta, Canada, T6G 2 J3
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Sarah J Curtis, MD Division of Pediatric Emergency Medicine, Department of Pediatrics & Women and Children's Health Research Institute
  More Information

No publications provided

Responsible Party: Sarah Curtis, Dr. Sarah Curtis, University of Alberta
ClinicalTrials.gov Identifier: NCT01133652     History of Changes
Other Study ID Numbers: Pro00004389, G049000062
Study First Received: May 18, 2010
Last Updated: August 23, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Venipuncture
Randomized Controlled Trial
Intravenous access
Children
 Pediatric Emergency Department
Peripheral intravenous catheterization
Catheterization, Peripheral Phlebotomy

ClinicalTrials.gov processed this record on May 19, 2013