Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound

Sponsor

Connecticut Children's Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05971745

Collaborator

Columbia University (Other), Newark Beth Israel Medical Center (Other), Cohen Children's Medical Center (Other), Gold Coast Hospital and Health Service (Other), Yale University (Other)

160

Enrollment

Locations

54.3

Anticipated Duration (Months)

26.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hip Effusion Septic Arthritis Transient Synovitis, Hip

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound

Actual Study Start Date :

Oct 15, 2019

Anticipated Primary Completion Date :

Apr 25, 2024

Anticipated Study Completion Date :

Apr 25, 2024

Outcome Measures

Primary Outcome Measures

The presence or absence of a hip effusion. [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.]
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).
The presence of absence of a hip effusion. [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.]
The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.

Secondary Outcome Measures

The size of the effusion. [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]
As measured by the pediatric emergency medicine provider in millimeters.
The location of the measurement of the effusion. [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.]
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.

Other Outcome Measures

Number of point-of-care ultrasound studies performed by PEM providers that have a different final diagnosis when compared to radiology ultrasound. [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.]
Investigators will compare the final diagnosis (hip effusion or no hip effusion) between point-of-care-ultrasound and radiology ultrasound to determine the number of discrepancies between the groups.
Association between negative point-of-care ultrasound and low to moderate Kocher score. [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.]
Investigators will determine whether the use of ultrasonography in patients with low or moderate Kocher score improves the ability to rule out septic arthritis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruchika M Jones	Hartford	Connecticut	United States	06106
2	Yale University	New Haven	Connecticut	United States	06550
3	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
4	Cohen Children's Medical Center	New Hyde Park	New York	United States	11042
5	Columbia University Medical Center	New York	New York	United States	10032
6	Gold Coast Hospital and Health Service	Southport	Queensland	Australia	4211