Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures

May 24, 2024 updated by: University of Chicago

The Diagnostic Accuracy of Pocket Size Ultrasound (PsUS) in the Detection of Pediatric Elbow Fractures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago/Comer Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

For Feasibility phase: children between the ages of 1-16 years olds

For Active phase: children between the ages of 1-16 years olds with isolated, acute (less than 48 hrs) elbow pain in the setting of adequate history of trauma

Exclusion Criteria:

Both phases:

  • Children <1 or >16 years old
  • Those with open fractures, gross deformities, multiple traumatic injuries, distal neurovascular compromise, unstable vital signs or hemodynamic instability, altered mental status, history of skeletal abnormalities, or past elbow fracture as well as wards of the state or those unable to provide consent
  • Patients who have a confirmed diagnosis of fracture at an outside institutions prior to arrival to the ED will also be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ultrasound Exam

The Study consists of two parts, a feasibility part and an active part.

Participants in the feasibility part of the study only undergo a pocket-sized ultrasound exam and are distinct (unique) group with no overlap or involvement with the active part.

Participants in the active part of the study undergo a pocket-sized ultrasound exam and continue with normal clinically indicated medical care in the ED. The comparison to the ultrasound images is either a X-ray if fracture is suspected or bedside nursemaid reduction if subluxation is suspected (participants will act as their own comparison based on their routine ED clinical management). There is no participation overlap with the feasibility part.
Device: Butterfly IQ
Butterfly IQ is a pocket sized ultrasound device. Each participant will undergo a ultrasound exam of both elbows using a pocket sized ultrasound device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture
Time Frame: 1ED visit (1 day)
FOR THE ACTIVE STUDY ONLY: Pocket-size ultrasound exam for each participant were interpreted as positive, negative or equivocal for signs of fracture. The feasibility study was not assessing for the presence or absence of fracture.
1ED visit (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound Exam Image Quality
Time Frame: Time period to complete since ultrasound exam per participant, approximately < 15 min
Each participant in both the feasibility and active parts of the study underwent a pocket sized ultrasound exam. 10 ultrasound images were obtained of each elbow and both elbows were imaged. Images will deemed adequate or inadequate for interpretation.
Time period to complete since ultrasound exam per participant, approximately < 15 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Holly Benjamin, MD, University of Chicago/Comer Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2022

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

June 7, 2023

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB21-0678

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study does not plan to share information with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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