Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05971745




Registration number
NCT05971745
Ethics application status
Date submitted
13/07/2023
Date registered
2/08/2023
Date last updated
2/08/2023

Titles & IDs
Public title
Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
Scientific title
Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
Secondary ID [1] 0 0
19-117
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Effusion 0 0
Septic Arthritis 0 0
Transient Synovitis, Hip 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The presence or absence of a hip effusion.
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
The presence of absence of a hip effusion.
Timepoint [2] 0 0
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.
Secondary outcome [1] 0 0
The size of the effusion.
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
The location of the measurement of the effusion.
Timepoint [2] 0 0
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.

Eligibility
Key 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
Minimum age
1 Month
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/04/2024
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast Hospital and Health Service - Southport
Recruitment postcode(s) [1] 0 0
4211 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
Connecticut Children's Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Columbia University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Newark Beth Israel Medical Center
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cohen Children's Medical Center
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Gold Coast Hospital and Health Service
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Yale University
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05971745
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ruchika M Jones, MD, MS
Address 0 0
Connecticut Children's
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ruchika M Jones, MD, MS
Address 0 0
Country 0 0
Phone 0 0
860-837-5596
Fax 0 0
Email 0 0
rjones@connecticutchildrens.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05971745