Diagnostic Accuracy of Handheld vs Traditional Ultrasound

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

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.

Study Overview

• Status: Completed
• Conditions: Image, Body
• Intervention / Treatment: Device: Portable, handheld point-of-care ultrasound device; Device: Cart-based point-of-care ultrasound device

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Lewis Katz School of Medicine at Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portable, Handheld Device; Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.	Device: Portable, handheld point-of-care ultrasound device; The patient will have an ultrasound performed using a handheld, portable device.
Active Comparator: Traditional, Cart-based Ultrasound; Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.	Device: Cart-based point-of-care ultrasound device; The patient will have an ultrasound performed using a traditional cart-based model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy	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).	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image Quality by Expert Review	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.	1 day

Collaborators and Investigators

• Sponsor: Temple University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 28766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No