Artificial Intelligence-Guided Lung Ultrasound by Nonexperts.
Cristiana Baloescu, John Bailitz, Baljash Cheema...
https://pubmed.ncbi.nlm.nih.gov/39813064Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05992324
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Led by Caption Health, Inc. · Updated on 2024-11-26
220
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the performance of Caption LungAI, a software designed to assist healthcare professionals in capturing lung ultrasound images. It focuses on patients experiencing shortness of breath with suspected B-Lines, a lung pathology. The study is interventional and is sponsored by Caption Health, Inc., seeking to compare image quality and diagnostic accuracy using this technology. Participants will undergo two lung ultrasound exams using an 8-zone protocol. One exam is performed by an expert without the software, lasting about 5 to 10 minutes. The second exam is done by a trained non-expert healthcare provider using Caption LungAI, taking approximately 15 to 20 minutes. Both sets of images will be analyzed for diagnostic quality and detection of B-Lines. During the study, researchers will assess the quality of images taken by trained professionals using Caption LungAI, the detection and significance of B-Lines, and the performance of remote image readers. These assessments will occur up to 24 weeks after study completion. Participants will be monitored throughout, and results will help understand the software's ability to aid non-expert providers in lung ultrasound imaging.
CONDITIONS
Brief Title
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over the age of 18
- Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-Lines
You will not qualify if you...
- Patients in extremis or those for whom a research lung ultrasound would not normally be performed due to other priorities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single day
Participants undergo two 8-zone lung ultrasound exams: one by an expert without Caption LungAI, and one by a trained healthcare professional using Caption LungAI to capture images.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 24 weeks
Participants' diagnostic image quality and B-Line detection are evaluated remotely for up to 24 weeks after study completion.
No participant visits required
Trial Site Locations
Total: 4 locations
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Completed
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
Completed
4
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Completed
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Research Team
A
Angeline Trinidad
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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