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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04720066
Other study ID # 0119-20-MMC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date January 2022

Study information

Verified date October 2021
Source Meir Medical Center
Contact Ayelet shles, MD
Phone 972525200407
Email ayeletsh22@clalit.org.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: pediatric patients presenting to the PED with the complaint of a limp or a lower limb pain - Exclusion Criteria: - trauma patients - patients with an obvious diagnosis other than pain resulting from the hip joint on their physical examination.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasound test
point of care ultrasound performed by PEM physicians to limping children presenting to the PED compared to radiologist performed ultrasound test.

Locations

Country Name City State
Israel Ayelet Shles Kfar Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary accuracy of POCUS examination for the detection of hip effusion among limping children POCUS examination results compared to formal radiology ultrasound examination performed . both examination are performed during the same 1 day ED visit.
See also
  Status Clinical Trial Phase
Recruiting NCT05971745 - Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound