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

This study has been completed.
Sponsor:
Collaborator:
American Academy of Pediatrics
Information provided by (Responsible Party):
Kenneth Yen, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00357799
First received: July 26, 2006
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Catheterization, Peripheral
Phlebotomy
Device: VeinViewer
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VeinViewer for Peripheral IV Placement in Children With Difficult IV Access

Resource links provided by NLM:


Further study details as provided by Children's Hospital and Health System Foundation, Wisconsin:

Primary Outcome Measures:
  • First attempt IV success rates [ Time Frame: Immediately after attempt ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of attempts required [ Time Frame: Immediately after attempts ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: October 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357799

Locations
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
Investigators
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
  More Information

Publications:
Responsible Party: Kenneth Yen, Associate Professor of Pediatrics (Emergency Medicine) and Population Health (Epidemiology), Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00357799     History of Changes
Other Study ID Numbers: CHW 06/139, GC 185
Study First Received: July 26, 2006
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital and Health System Foundation, Wisconsin:
Venipuncture
Randomized Controlled Trial
Intravenous Access
Children
Emergency Department Nursing
VeinViewer
Pediatrics
Emergency Nursing

ClinicalTrials.gov processed this record on November 25, 2014