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Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05870345
Enrollment
35
Registered
2023-05-23
Start date
2022-01-18
Completion date
2023-06-07
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elbow Fracture, Elbow Injury

Keywords

Pocket sized ultrasound, Pediatric elbow injury, Pediatric elbow fracture

Brief 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.

Interventions

Butterfly IQ is a pocket sized ultrasound device. Each participant will undergo a ultrasound exam of both elbows using a pocket sized ultrasound device.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Each participant receives the study intervention which is a pocket-sized ultrasound exam.

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture1ED 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.

Secondary

MeasureTime frameDescription
Ultrasound Exam Image QualityTime period to complete since ultrasound exam per participant, approximately < 15 minEach 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.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled through a single emergency room from January 2022 through April 2023.

Pre-assignment details

This study did not involved randomization. Patient were not randomized for this study. For both feasibility (N=22) and active (N=13) parts of this study, all participants who met inclusion criteria were enrolled. There was no crossover of participants of the two distinct parts of this study.

Participants by arm

ArmCount
Ultrasound Exam/Feasibility
Every participant will undergo a pocket-sized ultrasound exam. Both elbows were imaged. Age, gender, and race/ethnicity were not obtained or recorded.
22
Ultrasound Exam/Active
Every participant will undergo a pocket-sized ultrasound exam. The comparison to these images either a X-ray if fracture was suspected or beside nursemaid reduction if radial subluxation was suspected (participants acted as their own comparison based on their routine ED clinical management). Race/ethnicity were not obtained or recorded.
13
Total35

Baseline characteristics

CharacteristicUltrasound Exam/FeasibilityUltrasound Exam/ActiveTotal
Age, Categorical
<=18 years
22 Participants13 Participants35 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Customized
Age, Continuous Mean (Full Range)
7 years7 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
22 Participants13 Participants35 Participants
Sex/Gender, Customized
Sex/Gender Female (ACTIVE ONLY)
9 participants9 participants
Sex/Gender, Customized
Sex/Gender Male (ACTIVE ONLY)
4 participants4 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 13
other
Total, other adverse events
0 / 220 / 13
serious
Total, serious adverse events
0 / 220 / 13

Outcome results

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.

Time frame: 1ED visit (1 day)

Population: FOR THE ACTIVE STUDY ONLY: Images will be categorized as positive, negative or equivocal for signs of fracture. Pocket-sized US interpretation was compared to X-ray or performance of bedside nursemaid reduction as gold standard comparison.~The feasibility study was not assessing for the presence or absence of fracture and did not have data analyzed for this outcome of the study.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ultrasound Exam/ActivePocket Sized Ultrasound Elbow Exam Interpretation of FracturePocket-sized US interpretationPositive Fracture at ED visit on US8 Participants
Ultrasound Exam/ActivePocket Sized Ultrasound Elbow Exam Interpretation of FracturePocket-sized US interpretationNegative Fracture at ED visit on US5 Participants
Ultrasound Exam/ActivePocket Sized Ultrasound Elbow Exam Interpretation of FractureX-ray or Nursemaid Reduction Outcome (Nursemaid reduction considered negative for fracture)Negative Fracture at ED visit on US6 Participants
Ultrasound Exam/ActivePocket Sized Ultrasound Elbow Exam Interpretation of FractureX-ray or Nursemaid Reduction Outcome (Nursemaid reduction considered negative for fracture)Positive Fracture at ED visit on US7 Participants
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 frame: Time period to complete since ultrasound exam per participant, approximately < 15 min

Population: In each part of the study, participants were enrolled and both elbows were imaged, with ten views of each elbow, resulting in 20 images per participant. As result the feasibility study had 440 images reviewed and the active study had 260 images.

ArmMeasureGroupValue (NUMBER)
Ultrasound Exam/FeasibilityUltrasound Exam Image QualityAdequate Image Quality413 Images
Ultrasound Exam/FeasibilityUltrasound Exam Image QualityInadequate Image Quality27 Images
Ultrasound Exam/ActiveUltrasound Exam Image QualityAdequate Image Quality258 Images
Ultrasound Exam/ActiveUltrasound Exam Image QualityInadequate Image Quality2 Images

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026