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Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

Sponsor
University of Louisville (Other)
Overall Status
Completed
CT.gov ID
NCT00652548
Collaborator
(none)
100
Enrollment
1
Location
18
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department
    Study Start Date :
    Mar 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2009
    Actual Study Completion Date :
    Sep 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs [Single visit to emergency department]

    Secondary Outcome Measures

    1. Unblinded real-time bedside US by the ED physician vs. radiographs [Single ED visit]

    2. Interoperator reliability between the blinded reviewer and bedside ED physician [Single ED visit]

    3. FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs [Single ED visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 1-18 years

    • Pain from recent shoulder/clavicle injury

    • Intact neurovascular exam

    • Radiographs performed as part of normal ED evaluation

    Exclusion Criteria:

    • Hemodynamic instability

    • Multisystem trauma

    • Altered mental status

    • Open wounds to injured shoulder

    • Developmental delay

    • Prior radiographs at another clinic/hospital for this injury

    • Previous clavicle fracture on the affected side

    • Ultrasound gel allergy

    • Non-English-speaking parents/child (unable to give informed consent)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kosair Children's Hospital Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • University of Louisville

    Investigators

    • Principal Investigator: Keith P Cross, MD, University of Louisville

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keith Cross, Assistant Professor, University of Louisville
    ClinicalTrials.gov Identifier:
    NCT00652548
    Other Study ID Numbers:
    • 08-0007
    • IRB #08-0007
    • NHRO #1310
    First Posted:
    Apr 3, 2008
    Last Update Posted:
    Mar 31, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Keith Cross, Assistant Professor, University of Louisville
    Clavicle
    Fracture
    Ultrasound
    Radiation
    Additional relevant MeSH terms:
    Fractures, Bone

    Study Results

    No Results Posted as of Mar 31, 2017