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Hip POCUS for the Diagnosis of Pediatric Hip Effusion.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04720066
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Hip Effusion Diagnostic Test: Ultrasound test

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of Point of Care Ultrasound (POCUS) for the Diagnosis of Hip Effusion Among Children in the Pediatric Emergency Department
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    POCUS examination results compared to formal radiology ultrasound examination performed .


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • pediatric patients (age 0-18 years) presenting to the PED with the complaint of a limp or a lower limb pain
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720066


Contacts
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Contact: Ayelet shles, MD 972525200407 ayeletsh22@clalit.org.il

Locations
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Israel
Ayelet Shles Recruiting
Kfar Saba, Israel
Contact: Ayelet Shles, MD    972525200407    ayeletsh22@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT04720066    
Other Study ID Numbers: 0119-20-MMC
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meir Medical Center:
Hip Effusion, point of care sonography, pediatric,