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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Exam | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butterfly IQ | Device | Butterfly IQ is a pocket sized ultrasound device. Each participant will undergo a ultrasound exam of both elbows using a pocket sized ultrasound device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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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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:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Benjamin, MD | University of Chicago/Comer Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago/Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32507477 | Background | Tsou PY, Ma YK, Wang YH, Gillon JT, Rafael J, Deanehan JK. Diagnostic accuracy of ultrasound for upper extremity fractures in children: A systematic review and meta-analysis. Am J Emerg Med. 2021 Jun;44:383-394. doi: 10.1016/j.ajem.2020.04.071. Epub 2020 Apr 27. | |
| 31080032 | Background | Lee SH, Yun SJ. Diagnostic Performance of Ultrasonography for Detection of Pediatric Elbow Fracture: A Meta-analysis. Ann Emerg Med. 2019 Oct;74(4):493-502. doi: 10.1016/j.annemergmed.2019.03.009. Epub 2019 May 9. |
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This study does not plan to share information with other researchers
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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 were enrolled through a single emergency room from January 2022 through April 2023.
| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Exam | The Study consisted of two parts, a feasibility part and an active part. Participants in the feasibility part of the study only underwent a pocket-sized ultrasound exam and were a distinct (unique) group with no overlap or involvement with the active part. Each participant had 10 US images obtained. Participants in the active part of the study underwent a pocket-sized ultrasound exam and continued with normal clinically indicated medical care in the ED. The comparison to the ultrasound images was either a X-ray if fracture was suspected or bedside nursemaid reduction if subluxation was suspected (participants acted as their own comparison based on their routine ED clinical management). There was no participation overlap with the feasibility part. Each participant had 10 US images obtained. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feasibility |
| |||||||||||||
| Active |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Ultrasound Exam/Active |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 1ED visit (1 day) |
|
1 ED visit (single day).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound Exam/Feasibility | Every participant will undergo a pocket-sized ultrasound exam of each elbow. |
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Given time restraints of the study, slow recruitment and pandemic-related fluctuations in pediatric ED visits, the active portion of the study was not successful in enrolling the sample goal of 70. As a result, the sample size was too small to perform additional statistical tests given poor power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alisa Brennan, Pediatric Emergency Medicine Fellow, Physician, Co-PI | University of CHicago | 9787585263 | Brennanak@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2021 | May 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2022 | May 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D000092482 | Elbow Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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Each participant receives the study intervention which is a pocket-sized ultrasound exam.
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| 27278011 | Background | Ackermann O, Liedgens P, Eckert K, Chelangattucherry E, Ruelander C, Emmanouilidis I, Ruchholtz S. Ultrasound diagnosis of juvenile forearm fractures. J Med Ultrason (2001). 2010 Jul;37(3):123-7. doi: 10.1007/s10396-010-0263-x. Epub 2010 Apr 23. |
| 32023628 | Background | Ackermann O, Simanowski J, Eckert K. Fracture Ultrasound of the Extremities. Ultraschall Med. 2020 Feb;41(1):12-28. doi: 10.1055/a-1023-1782. Epub 2020 Feb 5. |
| 27277459 | Background | Eckert K, Ackermann O, Schweiger B, Radeloff E, Liedgens P. Ultrasound evaluation of elbow fractures in children. J Med Ultrason (2001). 2013 Oct;40(4):443-51. doi: 10.1007/s10396-013-0446-3. Epub 2013 Apr 16. |
| 23142008 | Background | Rabiner JE, Khine H, Avner JR, Friedman LM, Tsung JW. Accuracy of point-of-care ultrasonography for diagnosis of elbow fractures in children. Ann Emerg Med. 2013 Jan;61(1):9-17. doi: 10.1016/j.annemergmed.2012.07.112. Epub 2012 Nov 9. |
| 19145524 | Background | McNeil CR, McManus J, Mehta S. The accuracy of portable ultrasonography to diagnose fractures in an austere environment. Prehosp Emerg Care. 2009 Jan-Mar;13(1):50-2. doi: 10.1080/10903120802474513. |
| 28460717 | Background | Lau BC, Robertson A, Motamedi D, Lee N. The Validity and Reliability of a Pocket-Sized Ultrasound to Diagnose Distal Radius Fracture and Assess Quality of Closed Reduction. J Hand Surg Am. 2017 Jun;42(6):420-427. doi: 10.1016/j.jhsa.2017.03.012. Epub 2017 Apr 29. |
| 27697406 | Background | Burnier M, Buisson G, Ricard A, Cunin V, Pracros JP, Chotel F. Diagnostic value of ultrasonography in elbow trauma in children: Prospective study of 34 cases. Orthop Traumatol Surg Res. 2016 Nov;102(7):839-843. doi: 10.1016/j.otsr.2016.07.009. Epub 2016 Sep 30. |
| 17628559 | Background | Rennie L, Court-Brown CM, Mok JY, Beattie TF. The epidemiology of fractures in children. Injury. 2007 Aug;38(8):913-22. doi: 10.1016/j.injury.2007.01.036. Epub 2007 Jul 12. |
| 27976448 | Background | Poonai N, Myslik F, Joubert G, Fan J, Misir A, Istasy V, Columbus M, Soegtrop R, Goldfarb A, Thompson D, Dubrovsky AS. Point-of-care Ultrasound for Nonangulated Distal Forearm Fractures in Children: Test Performance Characteristics and Patient-centered Outcomes. Acad Emerg Med. 2017 May;24(5):607-616. doi: 10.1111/acem.13146. Epub 2017 Apr 27. |
| 31441332 | Background | Lee A, Colen DL, Fox JP, Chang B, Lin IC. Pediatric Hand and Upper Extremity Injuries Presenting to Emergency Departments in the United States: Epidemiology and Health Care-Associated Costs. Hand (N Y). 2021 Jul;16(4):519-527. doi: 10.1177/1558944719866884. Epub 2019 Aug 23. |
| 26177059 | Background | Naranje SM, Erali RA, Warner WC Jr, Sawyer JR, Kelly DM. Epidemiology of Pediatric Fractures Presenting to Emergency Departments in the United States. J Pediatr Orthop. 2016 Jun;36(4):e45-8. doi: 10.1097/BPO.0000000000000595. |
| 28249353 | Background | Bellavia MA, Cambise C, Coraci D, Maccauro G, Valassina A, Padua L. Ultrasound is a useful tool to evaluate nerve involvement in children with supracondylar humerus fractures. Muscle Nerve. 2017 Sep;56(3):E18-E20. doi: 10.1002/mus.25636. Epub 2017 Jun 5. No abstract available. |
| 22068062 | Background | Chaar-Alvarez FM, Warkentine F, Cross K, Herr S, Paul RI. Bedside ultrasound diagnosis of nonangulated distal forearm fractures in the pediatric emergency department. Pediatr Emerg Care. 2011 Nov;27(11):1027-32. doi: 10.1097/PEC.0b013e318235e228. |
| 17351413 | Background | Chen L, Baker MD. Novel applications of ultrasound in pediatric emergency medicine. Pediatr Emerg Care. 2007 Feb;23(2):115-23; quiz 124-6. doi: 10.1097/PEC.0b013e3180302c59. |
| 23114237 | Background | Barata I, Spencer R, Suppiah A, Raio C, Ward MF, Sama A. Emergency ultrasound in the detection of pediatric long-bone fractures. Pediatr Emerg Care. 2012 Nov;28(11):1154-7. doi: 10.1097/PEC.0b013e3182716fb7. |
| 20046499 | Background | Cho KH, Lee SM, Lee YH, Suh KJ. Ultrasound diagnosis of either an occult or missed fracture of an extremity in pediatric-aged children. Korean J Radiol. 2010 Jan-Feb;11(1):84-94. doi: 10.3348/kjr.2010.11.1.84. Epub 2009 Dec 28. |
| 31208078 | Background | Rykkje A, Carlsen JF, Nielsen MB. Hand-Held Ultrasound Devices Compared with High-End Ultrasound Systems: A Systematic Review. Diagnostics (Basel). 2019 Jun 15;9(2):61. doi: 10.3390/diagnostics9020061. |
| 16334848 | Background | Pudas T, Hurme T, Mattila K, Svedstrom E. Magnetic resonance imaging in pediatric elbow fractures. Acta Radiol. 2005 Oct;46(6):636-44. doi: 10.1080/02841850510021643. |
| 10535592 | Background | Skaggs DL, Mirzayan R. The posterior fat pad sign in association with occult fracture of the elbow in children. J Bone Joint Surg Am. 1999 Oct;81(10):1429-33. doi: 10.2106/00004623-199910000-00007. |
| 25615780 | Background | Supakul N, Hicks RA, Caltoum CB, Karmazyn B. Distal humeral epiphyseal separation in young children: an often-missed fracture-radiographic signs and ultrasound confirmatory diagnosis. AJR Am J Roentgenol. 2015 Feb;204(2):W192-8. doi: 10.2214/AJR.14.12788. |
| 29681446 | Background | Tokarski J, Avner JR, Rabiner JE. Reduction of Radiography with Point-of-Care Elbow Ultrasonography for Elbow Trauma in Children. J Pediatr. 2018 Jul;198:214-219.e2. doi: 10.1016/j.jpeds.2018.02.072. Epub 2018 Apr 19. |
| 18626636 | Background | Zuazo I, Bonnefoy O, Tauzin C, Borocco A, Lippa A, Legrand M, Chateil JF. Acute elbow trauma in children: role of ultrasonography. Pediatr Radiol. 2008 Sep;38(9):982-8. doi: 10.1007/s00247-008-0935-5. Epub 2008 Jul 15. |
| 20466368 | Background | Weinberg ER, Tunik MG, Tsung JW. Accuracy of clinician-performed point-of-care ultrasound for the diagnosis of fractures in children and young adults. Injury. 2010 Aug;41(8):862-8. doi: 10.1016/j.injury.2010.04.020. Epub 2010 May 13. |
| 11133538 | Background | Griffith JF, Roebuck DJ, Cheng JC, Chan YL, Rainer TH, Ng BK, Metreweli C. Acute elbow trauma in children: spectrum of injury revealed by MR imaging not apparent on radiographs. AJR Am J Roentgenol. 2001 Jan;176(1):53-60. doi: 10.2214/ajr.176.1.1760053. |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Patients were screened for age but age was only recorded for the ACTIVE component of this study. It was not collected for the feasibility part (there was also no crossover from the feasibility part of the study to the active part). | Age of each participant was not obtained for feasibility part of study. | Mean | Full Range | years |
|
| Sex/Gender, Customized | Sex/gender was only obtained for the ACTIVE component of this study. It was not collected for the feasibility part (there was also no crossover from the feasibility part of the study to the active part). | Gender was not obtained for the feasibility part of the study. | Number | participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Number | Images | Time period to complete since ultrasound exam per participant, approximately < 15 min | Images | Images |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Ultrasound Exam/Active | Every participant will undergo a pocket-sized ultrasound exam of each elbow. | 0 | 13 | 0 | 13 | 0 | 13 |
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