Diagnostic Accuracy of Handheld vs Traditional Ultrasound

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05196776

Enrollment

110

Registered

2022-01-19

Start date

2021-10-01

Completion date

2022-03-01

Last updated

2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Image, Body

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.

Interventions

DEVICEPortable, handheld point-of-care ultrasound device

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

DEVICECart-based point-of-care ultrasound device

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Accuracy	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

Measure	Time frame	Description
Image Quality by Expert Review	1 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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Portable, Handheld Device Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device. Portable, handheld point-of-care ultrasound device: The patient will have an ultrasound performed using a handheld, portable device.	53
Traditional, Cart-based Ultrasound Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine. Cart-based point-of-care ultrasound device: The patient will have an ultrasound performed using a traditional cart-based model.	56
Total	109

Baseline characteristics

Characteristic	Traditional, Cart-based Ultrasound	Total	Portable, Handheld Device
Age, Continuous	57 years	59 years	60 years
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	56 Participants	109 Participants	53 Participants
Sex: Female, Male Female	34 Participants	61 Participants	27 Participants
Sex: Female, Male Male	22 Participants	48 Participants	26 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 54	0 / 56
other Total, other adverse events	0 / 54	0 / 56
serious Total, serious adverse events	0 / 54	0 / 56

Outcome results

Primary