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Completed

NCT Number: NCT05971745

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

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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Key information

Conditions

Hip Effusion Arthritis Arthritis, Infectious Infections Joint Diseases Musculoskeletal Diseases Septic Arthritis Transient Synovitis, Hip

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gold Coast Hospital and Health Service, Southport, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The presence or absence of a hip effusion.

    Time frame: 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).

  2. The presence of absence of a hip effusion.

    Time frame: 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 outcomes

  1. The size of the effusion.

    Time frame: 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.

  2. The location of the measurement of the effusion.

    Time frame: 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 outcomes

  1. Number of point-of-care ultrasound studies performed by PEM providers that have a different final diagnosis when compared to radiology ultrasound.

    Time frame: 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.

  2. Association between point-of-care ultrasound and Kocher score (0-4).

    Time frame: 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 if the addition of ultrasonography results coupled with Kocher score (0-4; increased risk of septic arthritis with higher scores), which includes laboratory markers, increases the likelihood of septic arthritis.

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Collaborators

  • Cohen Children's Medical Center
  • Columbia University
  • Gold Coast Hospital and Health Service
  • Newark Beth Israel Medical Center
  • Yale University

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2023
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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