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

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.

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

Conditions
-----------------
Catheterization, Peripheral Phlebotomy

Intervention / Treatment
-----------------
* Device: Veinviewer
* Device: Ultrasound
* Other: Conventional technique


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venipuncture, Randomized Controlled Trial, Intravenous access, Children, Pediatric Emergency Department, Peripheral intravenous catheterization, Catheterization, Peripheral Phlebotomy