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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00357799
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : August 24, 2011
American Academy of Pediatrics
Information provided by (Responsible Party):
Kenneth Yen, Medical College of Wisconsin

Brief 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.


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.

Condition or disease Intervention/treatment Phase
Catheterization, Peripheral Phlebotomy Device: VeinViewer Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VeinViewer for Peripheral IV Placement in Children With Difficult IV Access
Study Start Date : October 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Active Comparator: VeinViewer Arm
Attempts at IV placement will be made with use of the VeinViewer Machine
Device: VeinViewer
Using the VeinViewer, IV attempts will be made

No Intervention: Conventional Method
IV attempted with conventional method

Primary Outcome Measures :
  1. First attempt IV success rates [ Time Frame: Immediately after attempt ]

Secondary Outcome Measures :
  1. Number of attempts required [ Time Frame: Immediately after attempts ]

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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presentation to the emergency department at Children's Hospital of Wisconsin (CHW)
  • 0 to 19 years of age
  • Requires a peripheral IV as determined by the examining physician
  • DIVA score ≥ 3
  • During times when VeinViewer™ machine is available
  • During hours when a VeinViewer™ trained participating nurse is on duty

Exclusion Criteria:

  • Central line available
  • Immunocompromised patient
  • Requirement for immediate IV placement (Patient's condition would potentially be compromised if there is a time delay in IV placement.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00357799

United States, Wisconsin
Children's Hospital of Wisconsin Emergency Department and Trauma Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Children's Hospital and Health System Foundation, Wisconsin
American Academy of Pediatrics
Principal Investigator: Kenneth Yen, MD MS Medical College of WIsconsin and Children's Research Institute
Principal Investigator: Anne Riegert, RN Children Hospital of Wisconsin Health Systems
Principal Investigator: Marc H Gorelick, MD MSCE Medical College of Wisconsin and Children's Research Institute

Responsible Party: Kenneth Yen, Associate Professor of Pediatrics (Emergency Medicine) and Population Health (Epidemiology), Medical College of Wisconsin Identifier: NCT00357799     History of Changes
Other Study ID Numbers: CHW 06/139, GC 185
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by Kenneth Yen, Medical College of Wisconsin:
Randomized Controlled Trial
Intravenous Access
Emergency Department Nursing
Emergency Nursing