Diagnostic Accuracy of Handheld vs Traditional Ultrasound

Temple University

Status: Completed

Conditions: Image, Body

Treatments: Device: Cart-based point-of-care ultrasound device; Device: Portable, handheld point-of-care ultrasound device

Study type: Interventional

Funder types: Other

Identifiers

NCT05196776

28766

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

110 participants in 2 patient groups

Portable, Handheld Device

Experimental group

Description:

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

Treatment:

Device: Portable, handheld point-of-care ultrasound device

Traditional, Cart-based Ultrasound

Active Comparator group

Description:

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

Treatment:

Device: Cart-based point-of-care ultrasound device