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

Catheterization Clinical Trial

— VISION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133652
• Other study ID #: Pro00004389
• Secondary ID: G049000062
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2010
• Last updated: August 23, 2012
• Start date: May 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Catheterization
• Peripheral Phlebotomy

Intervention

Device:
• Veinviewer
Veinviewer machine
• Ultrasound
Ultrasound

Other:
• Conventional technique
Conventional IV placement by nurses

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital Pediatric Emergency Department	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No