Diagnostic Accuracy of Handheld vs Traditional Ultrasound

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Image, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Portable, Handheld Device

Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.

Group Type EXPERIMENTAL

Portable, handheld point-of-care ultrasound device

Intervention Type DEVICE

The patient will have an ultrasound performed using a handheld, portable device.

Traditional, Cart-based Ultrasound

Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.

Group Type ACTIVE_COMPARATOR

Cart-based point-of-care ultrasound device

Intervention Type DEVICE

The patient will have an ultrasound performed using a traditional cart-based model.

Interventions

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Portable, handheld point-of-care ultrasound device

The patient will have an ultrasound performed using a handheld, portable device.

Intervention Type DEVICE

Cart-based point-of-care ultrasound device

The patient will have an ultrasound performed using a traditional cart-based model.

Intervention Type DEVICE

Eligibility Criteria

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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.