MedPath

Diagnostic Accuracy of Handheld vs Traditional Ultrasound

Not Applicable
Completed
Conditions
Image, Body
Interventions
Device: Portable, handheld point-of-care ultrasound device
Device: Cart-based point-of-care ultrasound device
Registration Number
NCT05196776
Lead Sponsor
Temple University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
110
Inclusion Criteria
  1. 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
  1. All other non-English and non-Spanish speaking patients
  2. Vulnerable groups
  3. Patients unable to consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Portable, Handheld DevicePortable, handheld point-of-care ultrasound devicePatients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.
Traditional, Cart-based UltrasoundCart-based point-of-care ultrasound devicePatients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.
Primary Outcome Measures
NameTimeMethod
Diagnostic Accuracy1 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 Outcome Measures
NameTimeMethod
Image Quality by Expert Review1 day

Using a Likert scale of 1-7 (1 = unable to assess image; 7 = highest quality), ultrasound fellowship-trained providers will assess the image quality of images obtained by each provide in the study.

Trial Locations

Locations (1)

Lewis Katz School of Medicine at Temple University

🇺🇸

Philadelphia, Pennsylvania, United States

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