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

NCT ID: NCT01133652

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Catheterization Peripheral Phlebotomy

Keywords

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Venipuncture Randomized Controlled Trial Intravenous access Children Pediatric Emergency Department Peripheral intravenous catheterization Catheterization, Peripheral Phlebotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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VeinViewer

The Veinviewer machine will be used to guide intravenous access.

Group Type ACTIVE_COMPARATOR

Veinviewer

Intervention Type DEVICE

Veinviewer machine

Ultrasound

The Ultrasound will be used to guide intravenous access.

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type DEVICE

Ultrasound

Conventional IV placement

IV will be placed using conventional technique

Group Type ACTIVE_COMPARATOR

Conventional technique

Intervention Type OTHER

Conventional IV placement by nurses

Interventions

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Veinviewer

Veinviewer machine

Intervention Type DEVICE

Ultrasound

Ultrasound

Intervention Type DEVICE

Conventional technique

Conventional IV placement by nurses

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Sarah Curtis

Dr. Sarah Curtis

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah J Curtis, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Pediatric Emergency Medicine, Department of Pediatrics & Women and Children's Health Research Institute

Locations

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Stollery Children's Hospital Pediatric Emergency Department

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 25897047 (View on PubMed)

Other Identifiers

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G049000062

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00004389

Identifier Type: -

Identifier Source: org_study_id