VeinViewer for Peripheral IV Placement in Children With Difficult Intravenous (IV) Access

Summary

Hypothesis: The first attempt success rate for peripheral IV insertion for children with difficult IV access (difficult IV access \[DIVA\] score ≥ 4) by nurses using the VeinViewer guided technique is better than conventional method of IV placement.

Specific Aims:

1. To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access
2. To validate the DIVA score

Design: Prospective randomized controlled trial/Convenience sample

Subjects: Children (0-18) presenting to the emergency department who require an IV as determined by examining physician and with a DIVA score ≥ 3 during times when VeinViewer machine is available and a VeinViewer trained participating nurse is on duty.

Variables:

Outcome Variables: First IV attempt success rate

Predictor Variables: IV technique used, other potential modifiers (age, weight, height, skin shade, indication for IV, history of prematurity and, vein visibility/palpability after tourniquet)

Methods: Subjects who meet inclusion criteria will be randomized to either conventional IV technique or VeinViewer guided technique. The nurse will attempt the IV depending on the randomization. Success or failure on first IV attempt will be recorded. If unsuccessful, other attempts will be tried until a successful IV is placed or the physician decides to give an alternative therapy that does not need IV access.

Statistics: A chi square test will be used to compare the proportion of subjects with successful first attempt IV placement using the VeinViewer technique to that using the conventional method with 95% confidence interval. We, the researchers, will look at the median number of attempts to place an IV in each of the groups. Logistic regression will be performed to test for independent associations. Information collected during the study will also be used for validation of the DIVA score.

Risks: No extra risks are expected above that of receiving a standard IV. The standard risk of bleeding, bruising, pain, and infection will be possible regardless of technique used. The VeinViewer does not expose the patient the ionizing radiation. The use of the VeinViewer technique may increase the time need to place an IV in.

Potential Benefits: With this study, we, the researchers, hope to improve the success rate of children with difficult IV placement in the Emergency Department.

Conditions

• Catheterization, Peripheral
• Phlebotomy

Interventions

DEVICE

VeinViewer

Using the VeinViewer, IV attempts will be made

Sponsors & Collaborators

• American Academy of Pediatrics

  collaborator OTHER

• Children's Hospital and Health System Foundation, Wisconsin

  lead OTHER

Principal Investigators

• Kenneth Yen, MD MS · Medical College of WIsconsin and Children's Research Institute

• Anne Riegert, RN · Children Hospital of Wisconsin Health Systems

• Marc H Gorelick, MD MSCE · Medical College of Wisconsin and Children's Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2010-10-31

Completion

2010-10-31

Countries

• United States

Study Locations