N/A
N=22
Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures
Elbow Injury · Elbow Fracture
Bottom Line
View on ClinicalTrials.gov: NCT05870345 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture — 8; 5; 7; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Butterfly IQ (Device)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture |
8; 5; 7; 6 | — |
| SECONDARY Ultrasound Exam Image Quality |
413; 258; 27; 2 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05870345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.