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

August 20, 2024 updated by: Ruchika Jones, Connecticut Children's Medical Center
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4211
        • Gold Coast Hospital and Health Service
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Ruchika M Jones
      • New Haven, Connecticut, United States, 06550
        • Yale University
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • New Hyde Park, New York, United States, 11042
        • Cohen Children's Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population are children 18 years and younger presenting to the Emergency Department at Connecticut Children's Medical Center with a chief complaint that necessitates hip ultrasonography as determined by the physician caring for the patient at the time of the visit. Those presenting during the study period of October 2019-December 2023 will be recruited. This is a multi-center, international study that will also be conducted in the Pediatric Emergency Departments at the following institutions: Connecticut Children's, Cohen Children's Medical Center, New York-Presbyterian / Columbia University Medical Center, Yale New Haven Hospital, Newark Beth Israel Medical Center, and Gold Coast Hospital (Queensland, Australia).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The presence or absence of a hip effusion.
Time Frame: 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.
The presence or absence of an effusion as determined by the pediatric emergency medicine physician performing the point-of-care-ultrasound study on both the affected and unaffected sides (i.e. right hip and left hip).
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.
The presence of absence of a hip effusion.
Time Frame: 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.
The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The size of the effusion.
Time Frame: 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
As measured by the pediatric emergency medicine provider in millimeters.
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
The location of the measurement of the effusion.
Time Frame: 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.
Pediatric emergency medicine physicians will measure an effusion at two designated locations. One location is based off of current published literature whereas the second is to provide a comparison to determine if the exact location alters the final diagnosis (effusion or no effusion). Investigators will determine whether the location along the angle of the neck affects the measurement obtained when compared with the current standard practice of measuring fluid along the widest part of the femoral neck.
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.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of point-of-care ultrasound studies performed by PEM providers that have a different final diagnosis when compared to radiology ultrasound.
Time Frame: 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.
Investigators will compare the final diagnosis (hip effusion or no hip effusion) between point-of-care-ultrasound and radiology ultrasound to determine the number of discrepancies between the groups.
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.
Association between point-of-care ultrasound and Kocher score (0-4).
Time Frame: 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.
Investigators will determine if the addition of ultrasonography results coupled with Kocher score (0-4; increased risk of septic arthritis with higher scores), which includes laboratory markers, increases the likelihood of septic arthritis.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Connecticut Children's Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yale University
Columbia University
Gold Coast Hospital and Health Service
Newark Beth Israel Medical Center
Cohen Children's Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ruchika M Jones, MD, MS, Connecticut Children's

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Each study site will enter data into Redcap hosted by the lead site, Connecticut Children's. Data will be available for review and combined by Connecticut Children's investigators for data analysis. Each participating site has completed a data use agreement with the lead site agreeing to this plan.

IPD Sharing Time Frame

Shared as patients are seen throughout the course of the study.

IPD Sharing Access Criteria

Only the designated study investigator at each participating site will have Redcap access for purposes of data entry only. Primary investigators at the lead site will have access to the combined data set for data analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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