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Clinical Trials/NCT05196776
NCT05196776
Completed
Not Applicable

Diagnostic Accuracy of a Portable, Handheld Point-of-Care Ultrasound Device vs a Traditional Cart-Based Model

Temple University1 site in 1 country110 target enrollmentOctober 1, 2021
ConditionsImage, Body

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Image, Body
Sponsor
Temple University
Enrollment
110
Locations
1
Primary Endpoint
Diagnostic Accuracy
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability.

Detailed Description

Patients who require a point-of-care ultrasound examination of their kidneys, gallbladder, heart, lung, or aorta will be enrolled. Once enrolled, the patient will be randomized to receive the point-of-care ultrasound using a portable, handheld ultrasound or a traditional cart based model. The ultrasound examinations will be performed by emergency medicine post-graduate year 1-3 residents or an ultrasound fellow and reviewed by the supervising emergency medicine attending physicians credentialed in performing and interpreting point-of-care ultrasound. Based on the clinical presentation, the provider will perform one of the following ultrasounds: cardiac to assess ejection fraction ( \<50%, 30-50%, \<30%), lung to assess for presence or absence of B-lines, gallbladder to assess for the presence or absence of gallstones, renal to assess for the presence or absence of hydronephrosis, or aorta to assess for the presence or absence of an aneurysm. The diagnostic accuracy of the portable, handheld and the cart-based model will be assessed using the following as the diagnostic standard: cardiology-interpreted echocardiogram, radiology-interpreted ultrasound or computed tomography, or quality review of the point-of-care ultrasound by 3 ultrasound fellowship trained physicians.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
March 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • English and Spanish-speaking patients, who require a gallbladder, cardiac, renal, aorta, or lung ultrasound based on the discretion of the treating physician.

Exclusion Criteria

  • All other non-English and non-Spanish speaking patients
  • Vulnerable groups
  • Patients unable to consent

Outcomes

Primary Outcomes

Diagnostic Accuracy

Time Frame: 1 day

The primary outcome will be difference in diagnostic accuracy between the two methods (the percent of diagnostic accuracy of the hand-held and the percent of diagnostic accuracy of the cart-based model).

Secondary Outcomes

  • Image Quality by Expert Review(1 day)

Study Sites (1)

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