Elbow Fracture Clinical Trial
Official title:
The Diagnostic Accuracy of Pocket Size Ultrasound (PsUS) in the Detection of Pediatric Elbow Fractures
Verified date | May 2024 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | June 7, 2023 |
Est. primary completion date | May 5, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago/Comer Children's Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture | 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 | Ultrasound Exam Image Quality | 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 |
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