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

The VISION STUDY: 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.

Study Overview

• Status: Completed
• Conditions: Catheterization; Peripheral Phlebotomy
• Intervention / Treatment: Device: Veinviewer; Device: Ultrasound; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2 J3
      • Stollery Children's Hospital Pediatric Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VeinViewer; The Veinviewer machine will be used to guide intravenous access.	Device: Veinviewer; Veinviewer machine
Active Comparator: Ultrasound; The Ultrasound will be used to guide intravenous access.	Device: Ultrasound; Ultrasound
Active Comparator: Conventional IV placement; IV will be placed using conventional technique	Other: Conventional technique; Conventional IV placement by nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts to successful IV placement	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
Time to successful placement of IV	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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: May 18, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Estimate): August 24, 2012
• Last Update Submitted That Met QC Criteria: August 23, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Children; Randomized Controlled Trial; Venipuncture; Intravenous access; Pediatric Emergency Department; Peripheral intravenous catheterization; Catheterization, Peripheral Phlebotomy
• Other Study ID Numbers: Pro00004389; G049000062 (Other Grant/Funding Number: Womens and Children's Health Research Institute)