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Clinical Trials/NCT01133652
NCT01133652CompletedPhase 4

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

University of Alberta2 sites in 1 country399 target enrollmentStarted: May 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
399
Locations
2
Primary Endpoint
Success or failure of peripheral IV placement on first attempt.

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
1 Day to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Number of attempts to successful IV placement(Within one hour of start of procedure)
  • Time to successful placement of IV(Within one hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sarah Curtis

Dr. Sarah Curtis

University of Alberta

Study Sites (2)

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