Lung Ultrasound for Shortness of Breath

Enrolling by invitation at 2 trial locations

Overseen By Yngvil Thomas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GE Healthcare

Disqualifiers: Extremis, Unable to consent, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test lung ultrasounds for individuals experiencing shortness of breath. Researchers compare different ultrasound devices and techniques to evaluate their effectiveness in examining the lungs. Participants will undergo two ultrasounds, one with AI assistance and one without, to gather data on lung conditions. Individuals with known or unknown lung issues who experience shortness of breath may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance lung diagnostics.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that lung ultrasound is safe for assessing shortness of breath?

Research has shown that lung ultrasounds, like those used in this study, are safe and easy for patients to handle. The Venue GO ultrasound machine is easy to carry and use in various settings. Although some reports mention battery issues, these can be managed by following safety instructions. This does not affect the ultrasound's safety, which remains non-invasive and risk-free for patients.

Similarly, the Vscan Air ultrasound machine provides quick and reliable images. It runs on batteries, is portable, and has undergone thorough durability testing, including drop tests. Its design ensures safe use in different environments, with no reported safety concerns for patients. Overall, both ultrasound machines are considered safe for use in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using lung ultrasound for diagnosing shortness of breath because it offers a non-invasive and radiation-free way to assess lung conditions quickly. Unlike traditional imaging methods like X-rays or CT scans, these ultrasounds can be performed at a patient's bedside, providing immediate results. The trial explores two innovative ultrasound systems: the Venue GO system with Caption Lung AI and the Vscan Air handheld ultrasound with Caption AI. The AI-enhanced systems assist medical professionals in capturing high-quality images more efficiently, potentially improving diagnostic accuracy and speed. This approach could revolutionize how quickly and effectively healthcare providers diagnose and manage respiratory issues.

What evidence suggests that lung ultrasound is effective for shortness of breath?

Research has shown that lung ultrasounds effectively identify the causes of breathing difficulties. In this trial, participants will be divided into different cohorts to evaluate various ultrasound systems. Cohort 2 will use the Venue GO ultrasound system, which studies have found helps doctors quickly determine if the issue is with the heart or lungs, potentially shortening hospital stays and lowering costs. Cohort 1 will use the Vscan Air handheld ultrasound, known for its clear images and ease of use, making it a valuable tool in emergencies. Both devices enable doctors to view the lungs and nearby areas, improving the speed and accuracy of diagnosis. This can lead to better outcomes and quicker treatment for patients with breathing problems. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients experiencing shortness of breath who may have lung-related health issues. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

Inclusion Criteria

I have lung problems or I'm short of breath without a known lung issue.

I am over 22 years old.

Exclusion Criteria

I am unable to give consent by myself.

Patients in extremis and/or patients in whom a lung ultrasound would not normally be performed

Patients who are prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ultrasound Examination

Participants undergo lung ultrasound examinations using different devices and methods to collect diagnostic-quality images

7 months

Multiple visits for ultrasound exams

Follow-up

Participants are monitored for image quality and inter-rater variability

7 months

What Are the Treatments Tested in This Trial?

Interventions

• Lung Ultrasound

Trial Overview The study is testing the use of lung ultrasound as a tool to examine patients with breathing difficulties. Participants will undergo two ultrasound exams to validate this method in a prospective, non-randomized setting.

How Is the Trial Designed?

Group I: Cohort 2 -Device 2 Experimental Treatment 1 Intervention

Cohort 2 will utilize the Venue GO ultrasound system to perform a 12-zone lung ultrasound (LUS) exam. All Qualified users using Caption Lung AI will be required to capture at least 2 clips per zone before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam). The Qualified user will use the same ultrasound system but without Caption Lung AI (Control Exam).

Group II: Cohort 1 -Device 1 Experimental Treatment 1 Intervention

Cohort 1 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform an 8-zone lung ultrasound (LUS) exam. The Trained HCP will be required to capture at least 2 clips per zone using an ultrasound with Caption AI before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam). The Expert LUS user will use the same ultrasound system but without Caption Lung AI (Control Exam).

Group III: Cohort 0 - Vscan (no AI) Active Control 1 Intervention

Cohort 0 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform the following lung ultrasound (LUS) exams.: Each patient will undergo 2 8-zone lung examinations which will be a combination of the enrollment distribution listed below equating to up to 30 subjects with 2 scans per subject (60 scans).

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Rush University Medical Center

Collaborator

Trials

448

Recruited

247,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Citations

1. gehealthcare.com gehealthcare.com/insights/article/emergency-department-ultrasound-its-recent-impact-and-use?srsltid=AfmBOooXlNIn8yehiM7CzK04hLHPhvU_p2z_ZSErzNtEyAU54X_la3Yx

Emergency Department Ultrasound: Its Recent Impact and ... Shortness of breath: Point-of-care ultrasound can determine whether heart or lung problems are responsible for a patient's shortness of breath.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10871481/

Point-of-care ultrasound (POCUS): Assessing patient ... The GE Venue GO Ultrasound System was used in this study's POCUS encounters; we now specify this in the methods section (page 8, lines 141–142).

3. radiologybusiness.com radiologybusiness.com/topics/medical-imaging/ultrasound-imaging/bedside-pocus-could-save-hospitals-millions-when-used-patients-shortness-breath

Bedside POCUS could save hospitals millions when used ... Use of point-of-care ultrasound (POCUS) in patients presenting to emergency departments with shortness of breath can significantly decrease ...

4. beckersasc.com beckersasc.com/cardiology/point-of-care-ultrasound-improves-dyspnea-patient-outcomes/

Point-of-care ultrasound improves dyspnea patient outcomes In a 200-patient trial, ultrasound-guided diagnoses reduced average length of stay by 3.6 days and cut total hospitalization costs by more than ...

5. physiciansweekly.com physiciansweekly.com/post/portable-ultrasound-reduces-dyspnea-hospital-los-costs

Pocket Ultrasound Reduces Dyspnea Hospital LOS & Costs The findings suggest that portable ultrasound, when integrated into workflows, can enhance hospital efficiency, though broader adoption remains ...

6. recalls-rappels.canada.ca recalls-rappels.canada.ca/en/alert-recall/venue-fit-and-venue-go

Venue Fit and Venue Go - Canada.ca - Recalls and safety alerts The battery for certain Venue Go and Venue Fit ultrasound systems with software versions R2, R3, R4, and R5 can potentially develop an internal failure.

7. probomedical.com probomedical.com/wp-content/uploads/2021/09/GE-Venue-R2-Data-Sheet.pdf

GE Healthcare - Venue Ultrasound System Datasheet The Venue system is built on a solid foundation of ploppable image quality needed for scan-and-go users. GE Healthcare. Page 2. General Specification.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301562920304269

Portable Pocket-Sized Ultrasound Scanner for the ... Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in coronavirus disease 2019 (COVID-19) patients.

9. bfarm.de bfarm.de/SharedDocs/Kundeninfos/EN/19/2025/13875-25_kundeninfo_en.pdf?__blob=publicationFile

URGENT FIELD SAFETY NOTICE You can continue to use your Venue Go and Venue Fit system after following the actions below: 1) Turn the system 'Off' and unplug the system from the wall ...

10. gehealthcare.com gehealthcare.com/products/ultrasound/point-of-care-ultrasound/venuego?srsltid=AfmBOoruha5Yvel-8on_alCbp52I_mTC_Vg6Rg3yHnTEG7Q9WGY2Ke1-

Venue Go Ultrasound A take anywhere ultrasound system, Venue Go™ provides a portable and adaptable way to access a patient's medical status at your point of care.