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Ultrasound Assisted Peripheral Venous Access in Young Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00557154
First Posted: November 12, 2007
Last Update Posted: February 15, 2017
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.
Collaborator:
Children's Miracle Network
Information provided by:
University of California, Davis
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound Assisted Peripheral Venous Access in Young Children: A Pilot and Feasibility Randomized Controlled Trial

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00557154     History of Changes
Other Study ID Numbers: 200210274
S-9400847-018LA ( Other Identifier: Other )
First Submitted: November 8, 2007
First Posted: November 12, 2007
Last Update Posted: February 15, 2017
Last Verified: November 2007

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