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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Month - 18 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05971745
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Connecticut Children's Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ruchika M Jones, MD, MS
Principal Investigator Affiliation	Connecticut Children's
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Australia, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hip Effusion, Septic Arthritis, Transient Synovitis, Hip

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ruchika M Jones, Hartford, Connecticut

Status

Recruiting

Address

Ruchika M Jones

Hartford, Connecticut, 06106

Site Contact

Ruchika M Jones, MD, MS

[email protected]

860-837-5596

Yale University, New Haven, Connecticut

Status