- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04720066
Hip POCUS for the Diagnosis of Pediatric Hip Effusion.
Accuracy of Point of Care Ultrasound (POCUS) for the Diagnosis of Hip Effusion Among Children in the Pediatric Emergency Department
Limping is a common complaint among children presenting in the Pediatric ED the evaluation of a limp among infants and toddlers is challenging doe to the lack of specific history and the difficulty in locating the pain - therefore hip sonography is frequently used in the clinical evaluation of these children.
Sonographic examination for the diagnosis of hip effusion is routinely performed by the radiologist, however, since the integration of Point of care Ultrasound (POCUS) as part of the clinical evaluation of children in the ED in many application - Hip pocus is frequently performed by pediatric Emergency Medicine physicians.
The existing data on hip POCUS is scarce and comprised of small uncontrolled studies.
We aimed to examine the specificity and sensitivity of hip Pocus performed by pediatric emergency physicians by comparing it to the scan performed by the radiologist.
the primary outcome measurement is the ability of the POCUS exam to identify or rule out the existence of hip effusion as demonstrated in the formal radiological Ultrasound scan.
Study Overview
Detailed Description
Children (0-18 years) presenting to the PED in Meir medical center with limp pain (not due to trauma) or a limp are recruited After consenting to participate in the study and completing the registration process the primary physician who is an approved researcher by the institutes IRB will perform hip POCUS as part of the clinical evaluation and will record his interpretation in the medical file. A formal ultrasound scan will be perfumed additionally by the radiologist. Both examination will be reviewed by POCUS lead physician and the Pediatric radiologist.
The patient's clinical and epidemiological data will be extracted from the electronic chart.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ayelet Shles, MD
- Phone Number: 972525200407
- Email: ayeletsh22@clalit.org.il
Study Locations
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Kfar Saba, Israel
- Recruiting
- Ayelet Shles
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Contact:
- Ayelet Shles, MD
- Phone Number: 972525200407
- Email: ayeletsh22@clalit.org.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- pediatric patients (age 0-18 years) presenting to the PED with the complaint of a limp or a lower limb pain
Description
Inclusion Criteria: pediatric patients presenting to the PED with the complaint of a limp or a lower limb pain
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Exclusion Criteria:
- trauma patients
- patients with an obvious diagnosis other than pain resulting from the hip joint on their physical examination.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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accuracy of POCUS examination for the detection of hip effusion among limping children
Time Frame: both examination are performed during the same 1 day ED visit.
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POCUS examination results compared to formal radiology ultrasound examination performed .
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both examination are performed during the same 1 day ED visit.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0119-20-MMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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