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OpenTrials
Completed

NCT Number: NCT05196776

Diagnostic Accuracy of Handheld vs Traditional Ultrasound

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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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • All other non-English and non-Spanish speaking patients
  • Vulnerable groups
  • Patients unable to consent

Treatment and study plan

Portable, handheld point-of-care ultrasound device

Device

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

Cart-based point-of-care ultrasound device

Device

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

Primary outcomes

  1. Diagnostic Accuracy

    Time frame: 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 outcomes

  1. Image Quality by Expert Review

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2022
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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