Clinical trial NCT01133652: Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques
Official title: The VISION STUDY: Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Catheterization
Peripheral Phlebotomy
Keywords: Venipuncture
Randomized Controlled Trial
Intravenous access
Children
Pediatric Emergency Department
Peripheral intravenous catheterization
Catheterization, Peripheral Phlebotomy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 399
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Success or failure of peripheral IV placement on first attempt.
timeFrame: Within one hour of start of procedure
Secondary outcomes:
measure: Number of attempts to successful IV placement
timeFrame: Within one hour of start of procedure
measure: Time to successful placement of IV
timeFrame: Within one hour
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital Pediatric Emergency Department
state: Alberta
Study officials:
affiliation: Division of Pediatric Emergency Medicine, Department of Pediatrics & Women and Children's Health Research Institute
name: Sarah J Curtis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.