Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures
Condition: Elbow Injury; Elbow Fracture
MeSH terms: Fractures, Bone; Elbow Fractures; Elbow Injuries
Study type: Interventional

Summary: 
      The main purpose of this project is to investigate the accuracy of pocket-sized ultrasound
      (PsUS) in the diagnosis of pediatric elbow fractures. The primary research objective is to
      determine the test performance characteristics of PSUS performed by pediatric emergency
      medicine physicians compared to radiography for the detection of pediatric elbow fractures.
      The project will consist of two parts, first involving a feasibility study and followed by an
      active study. The feasibility study will aim to answer if providers can perform an adequate
      elbow ultrasound exam after a brief study training. The active study will investigate the
      initial accuracy of the PsUS. Participants will be asked in either the feasibility or the
      active phases of the study to undergo a brief pocket-sized ultrasound elbow exam of both
      elbows. Patient will continue to receive their previously determined clinical ED management.
      In the active phase of the study, participant's elbow X-rays or if patient underwent bedside
      nursemaid reduction will be the comparison to pocket-sized ultrasound images.
    

Detailed description: 
      The main purpose of this project is to investigate the accuracy of pocket-sized ultrasound
      (PsUS) in the diagnosis of pediatric elbow fractures. The primary research objective is to
      determine the test performance characteristics of PSUS performed by pediatric emergency
      medicine physicians compared to radiography for the detection of pediatric elbow fractures.
      The project will consist of two parts, first involving a feasibility study and followed by an
      active study.

      This project will consist of two parts, involving first a brief feasibility phase followed by
      a pilot study conducted in an urban pediatric emergency department (Comer Children's Hospital
      in Chicago, IL). For the feasibility phase, the purpose is to demonstrate that novice PsUS
      users are able to obtain accurate and adequate imaging for interpretation. This phase will
      initially involve the study providers receiving the elbow PsUS exam training. Once trained,
      each study provider will obtain 3 elbow exams of participants between the ages of 1-16 years
      old. Providers will use the standardized views reviewed in the ultrasound training to perform
      the exam, with verbal consent obtained from each participant's parent for inclusion in the
      feasibility study. These images will be reviewed by study staff to ensure US examiners are
      obtaining the correct standardized views.

      Once the feasibility exams are completed, the study providers are able to begin active study
      recruitment which will involve recruiting children between the ages of 1-16 years old with
      isolated acute elbow pain. Parents will initially be approached in the emergency department
      (ED), with written consent obtained if interested and eligible. Once consented, patients will
      undergo bilaterally standardized elbow exams using the pocket-sized ultrasound. All images
      will be stored on a password protected, cloud-based imaging database with all identifying
      information removed. After the exam, a basic assessment of the images will be made by the
      bedside ultrasound provider, as positive, negative or equivocal for signs of elbow fracture,
      but before reviewing any radiographic imaging. A positive PsUS will be defined as the
      presence of signs of elbow fracture, either as direct signs including cortical
      discontinuities or indirect signs including posterior fat pad with or without
      lipohemarthrosis on ultrasound exam. Following the ultrasound exam, patients will undergo
      standard clinical care for acute elbow injury per primary ED team which may consist of Xray
      or possible bedside nursemaid reduction. When applicable, study investigators will review the
      final blinded radiology readings of the initial or subsequent x-ray images after the patient
      encounter. Additionally, research staff will also attempt to follow up with participants
      after their ED visit for their elbow injury to determine if any additional radiographic
      imaging or care was obtained and if subsequent occult fractures were discovered on later
      imaging that may have been missed on the initial evaluation.

      The primary aim of the feasibility portion of the study is to determine acceptability of the
      PsUS study training to obtain adequate elbow images. The primary aim of the active study is
      to compare the initial test performance characteristics of PSUS performed by bedside
      physicians compared to standard radiography in the diagnosis of pediatric elbow fractures.
    

Intervention name(s): Butterfly IQ
Intervention type(s): Device
Intervention description(s): Butterfly IQ is a pocket sized ultrasound device. Each participant will undergo a ultrasound exam of both elbows using a pocket sized ultrasound device.
Intervention model: Single Group Assignment
Intervention model description: Each participant receives the study intervention which is a pocket-sized ultrasound exam.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pocket sized ultrasound; Pediatric elbow injury; Pediatric elbow fracture