Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures
NCT ID: NCT05870345
Last Updated: 2024-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-01-18
2023-06-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Ultrasound Exam
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.
Butterfly IQ
Butterfly IQ is a pocket sized ultrasound device. Each participant will undergo a ultrasound exam of both elbows using a pocket sized ultrasound device.
Interventions
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Butterfly IQ
Butterfly IQ is a pocket sized ultrasound device. Each participant will undergo a ultrasound exam of both elbows using a pocket sized ultrasound device.
Eligibility Criteria
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Inclusion Criteria
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
* 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
1 Year
16 Years
ALL
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Holly Benjamin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago/Comer Children's Hospital
Locations
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University of Chicago/Comer Children's Hospital
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB21-0678
Identifier Type: -
Identifier Source: org_study_id
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