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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05971745
Registration number
NCT05971745
Ethics application status
Date submitted
13/07/2023
Date registered
2/08/2023
Date last updated
22/08/2024
Titles & IDs
Public title
Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
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Scientific title
Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
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Secondary ID [1]
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19-117
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip Effusion
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Septic Arthritis
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Transient Synovitis, Hip
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The presence or absence of a hip effusion.
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Assessment method [1]
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The presence or absence of an effusion as determined by the pediatric emergency medicine physician performing the point-of-care-ultrasound study on both the affected and unaffected sides (i.e. right hip and left hip).
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Timepoint [1]
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From the time the point-of-care ultrasound is performed by the physician during the emergency department visit through study completion, average of 2 years.
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Primary outcome [2]
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The presence of absence of a hip effusion.
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Assessment method [2]
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The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.
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Timepoint [2]
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From the time the radiologist reviews the ultrasound as performed by the radiology technician during the emergency department visit, through study completion, average of 2 years.
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Secondary outcome [1]
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The size of the effusion.
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Assessment method [1]
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As measured by the pediatric emergency medicine provider in millimeters.
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Timepoint [1]
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From the time the point-of-care ultrasound is performed by the physician during the emergency department visit to study completion, average of 2 years
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Secondary outcome [2]
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The location of the measurement of the effusion.
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Assessment method [2]
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Pediatric emergency medicine physicians will measure an effusion at two designated locations. One location is based off of current published literature whereas the second is to provide a comparison to determine if the exact location alters the final diagnosis (effusion or no effusion). Investigators will determine whether the location along the angle of the neck affects the measurement obtained when compared with the current standard practice of measuring fluid along the widest part of the femoral neck.
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Timepoint [2]
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Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
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Eligibility
Key inclusion criteria
* Age 18 years or younger
* Clinical presentation necessitating hip ultrasonography as determined by the evaluating clinician
* Study physician available at the time of presentation to ED
* Patient or legal guardian provides consent
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Minimum age
1
Month
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Children who present when a study physician is not available or those for whom consent is not given.
* Children who have had hip ultrasound imaging prior to their ED visit. Children with prior hip/pelvis x-rays will not be excluded.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/04/2024
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Sample size
Target
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Accrual to date
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Final
161
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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Country [2]
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United States of America
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State/province [2]
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New Jersey
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Country [3]
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United States of America
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State/province [3]
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New York
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Funding & Sponsors
Primary sponsor type
Other
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Name
Connecticut Children's Medical Center
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).
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Trial website
https://clinicaltrials.gov/study/NCT05971745
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Ruchika M Jones, MD, MS
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Address
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Connecticut Children's
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ruchika M Jones, MD, MS
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Address
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Country
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Phone
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860-837-5596
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05971745
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