Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Fractures

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kosair Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children age 1-18 years presenting to a tertiary center pediatric emergency department complaining of recent traumatic shoulder injury.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Unblinded real-time bedside US by the ED physician vs. radiographs	Single ED visit
Interoperator reliability between the blinded reviewer and bedside ED physician	Single ED visit
FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs	Single ED visit

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: April 2, 2008
• First Posted (Estimate): April 3, 2008

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Clavicle; Fracture; Radiation
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 08-0007; IRB #08-0007; NHRO #1310