Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures
United States35 participantsStarted 2022-01-18
Plain-language 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.
Who can participate
Age range
1 Year – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture