Ultrasound Assisted Peripheral Venous Access in Young Children

This study has been completed.
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00557154
First received: November 8, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

The purpose of this study is to learn how the use of ultrasound helps with the placement of an intravenous (i.v.) catheter in young children.


Condition Intervention
Catheterization, Peripheral
Device: ultrasound
Device: standard technique for venipuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound Assisted Peripheral Venous Access in Young Children: A Pilot and Feasibility Randomized Controlled Trial

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • venous visualization (with ultrasound) and venipuncture success rate [ Time Frame: one year ]

Secondary Outcome Measures:
  • Anticipated difficulty of venipuncture (rated on visual analog scale) [ Time Frame: one year ]

Enrollment: 44
Study Start Date: August 2003
Study Completion Date: July 2004
Arms Assigned Interventions
Experimental: 1
Ultrasound used to visualize peripheral venous anatomy. This guides subsequent attempts at venipuncture.
Device: ultrasound
ultrasound used to identify target vein
Active Comparator: 2
Routine venipuncture using standard methods.
Device: standard technique for venipuncture
routine equipment

Detailed Description:

In an academic pediatric Emergency Depratment (ED), we performed a randomized clinical trial of children < 7 years of age, who required i.v. access and who had failed the first i.v. attempt. We randomized patients to either continued standard i.v. attempts or ultrasound-assisted attempts. Clinicians involved in the study received one hour of training in ultrasound localization of peripheral veins. In the ultrasound group, vein localization was performed by an ED physician who marked the skin overlying the target vessel. Intravenous cannulation attempts were then immediately performed by a pediatric ED nurse who relied on the skin mark for vessel location. We allowed for technique cross-over after two failed i.v. attempts. We recorded success rate and location of access attempts.

  Eligibility

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Less than 7 years of age
  • Emergency Department patients
  • Parents available for consent

Exclusion Criteria:

  • Critical illness
  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: NCT00557154

Locations
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Children's Miracle Network
Investigators
Principal Investigator: Aaron E Bair, MD University of California, Davis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00557154     History of Changes
Other Study ID Numbers: S-9400847-018LA
Study First Received: November 8, 2007
Last Updated: November 8, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Pediatrics
Venous access
Emergency

ClinicalTrials.gov processed this record on July 22, 2014