Clinical trial NCT05971745: Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
Official title: Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Effusion
Septic Arthritis
Transient Synovitis, Hip
Keywords: Point of Care Ultrasound
Hip Effusion
Pediatric Emergency Medicine
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Newark Beth Israel Medical Center
name: Cohen Children's Medical Center
name: Gold Coast Hospital and Health Service
name: Yale University
First posted: 2023-08-02
Enrollment: 161
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population are children 18 years and younger presenting to the Emergency Department at Connecticut Children's Medical Center with a chief complaint that necessitates hip ultrasonography as determined by the physician caring for the patient at the time of the visit. Those presenting during the study period of October 2019-December 2023 will be recruited. This is a multi-center, international study that will also be conducted in the Pediatric Emergency Departments at the following institutions: Connecticut Children's, Cohen Children's Medical Center, New York-Presbyterian / Columbia University Medical Center, Yale New Haven Hospital, Newark Beth Israel Medical Center, and Gold Coast Hospital (Queensland, Australia).

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).

Detailed description: The purpose of this study is to determine that the accuracy of trained pediatric emergency medicine providers to diagnose hip effusion using point-of-care ultrasound (POCUS) is non-inferior to the reference standard of radiology ultrasound (RADUS). Additionally, the investigators seek to compare how POCUS performs against other clinical tests or investigations for the diagnosis of septic arthritis. The investigators hypothesize that trained EM providers will be able to diagnose hip effusions with high (\>90%) accuracy compared to studies conducted by the Department of Radiology.

Eligibility criteria: 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

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.

Primary outcomes:
measure: The presence or absence of a hip effusion.
timeFrame: 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.
measure: The presence of absence of a hip effusion.
timeFrame: 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.
Secondary outcomes:
measure: The size of the effusion.
timeFrame: 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
measure: The location of the measurement of the effusion.
timeFrame: 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.
Other outcomes:
measure: Number of point-of-care ultrasound studies performed by PEM providers that have a different final diagnosis when compared to radiology ultrasound.
timeFrame: 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.
measure: Association between point-of-care ultrasound and Kocher score (0-4).
timeFrame: 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.
Locations:
city: Hartford
country: United States
facility: Ruchika M Jones
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Southport
country: Australia
facility: Gold Coast Hospital and Health Service
state: Queensland
Study officials:
affiliation: Connecticut Children's
name: Ruchika M Jones, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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