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Completed

NCT Number: NCT01133652

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

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.

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Key information

Age range

1 day–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stollery Children's Hospital Pediatric Emergency Department

Edmonton, Alberta, T6G 2 J3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VeinViewer

Device

Veinviewer machine

Ultrasound

Device

Ultrasound

Conventional Technique

Other

Conventional IV placement by nurses

Primary outcomes

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

    Time frame: Within one hour of start of procedure

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

Secondary outcomes

  1. Number of attempts to successful IV placement

    Time frame: Within one hour of start of procedure

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

  2. Time to successful placement of IV

    Time frame: Within one hour

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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: VISION

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 31, 2010
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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