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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05870345
Other study ID # IRB21-0678
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2022
Est. completion date June 7, 2023

Study information

Verified date May 2024
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
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.

Locations

Country Name City State
United States University of Chicago/Comer Children's Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (26)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

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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