Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures

NCT05870345 | Completed Results FDA Device

• 1 other identifier: IRB21-0678
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Elbow Injury; Elbow Fracture

Keywords

Pocket sized ultrasound; Pediatric elbow injury; Pediatric elbow fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ultrasound Exam Image Quality

  Time period to complete since ultrasound exam per participant, approximately < 15 min

Study Arms (1)

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.

Device: Butterfly IQ

Interventions

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.

Ultrasound Exam

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago/Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Related Publications (26)

• 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.

  PMID: 32507477 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.

  PMID: 31080032 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.

  PMID: 27278011 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.

  PMID: 32023628 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.

  PMID: 27277459 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.

  PMID: 23142008 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.

  PMID: 19145524 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.

  PMID: 28460717 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.

  PMID: 27697406 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.

  PMID: 17628559 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.

  PMID: 27976448 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.

  PMID: 31441332 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.

  PMID: 26177059 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.

  PMID: 28249353 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.

  PMID: 22068062 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.

  PMID: 17351413 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.

  PMID: 23114237 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.

  PMID: 20046499 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.

  PMID: 31208078 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.

  PMID: 16334848 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.

  PMID: 10535592 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.

  PMID: 25615780 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.

  PMID: 29681446 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.

  PMID: 18626636 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.

  PMID: 20466368 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.

  PMID: 11133538 BACKGROUND

MeSH Terms

Conditions

Elbow Injuries; Elbow Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Limitations and Caveats

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.

Results Point of Contact

• Title: Alisa Brennan, Pediatric Emergency Medicine Fellow, Physician, Co-PI
• Organization: University of CHicago

Brennanak@gmail.com

9787585263

Study Officials

• Holly Benjamin, MD

  University of Chicago/Comer Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 23, 2023
• Study Start: January 18, 2022
• Primary Completion: May 5, 2023
• Study Completion: June 7, 2023
• Last Updated: June 20, 2024
• Results First Posted: June 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)