Caption LungAI for Shortness of Breath
This study is testing a software called Caption LungAI. This software helps healthcare professionals who are not ultrasound experts to take high-quality lung ultrasound images. The study wants to see if Caption LungAI can help detect B-lines (a sign of fluid in the lungs) in people experiencing shortness of breath. You might be able to join if you are over 18, have shortness of breath, and your doctors suspect you have B-lines. The study is looking for 220 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 220 participants. It compares lung ultrasounds performed by an expert with those done by a non-expert using Caption LungAI.
- What's involved
- You would undergo two lung ultrasound exams. One exam will be done by an expert, and the other by a healthcare provider using Caption LungAI.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your diagnostic image quality and B-line detection will be measured for up to 24 weeks after completing the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
At a glance
Conditions
NCT05992324
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Yale New Haven Hospital
New Haven, Connecticutstudy coordinator listed
Recruiting
Northwestern University
Chicago, Illinoisno site contact published
Completed
Rush University Medical Center
Chicago, Illinoisno site contact published
Completed
The Moses H. Cone Memorial Hospital
Greensboro, North Carolinano site contact published
Completed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Diagnostic Image Quality (Trained Healthcare Professional)Up to 24 weeks from completion of the study.
Evaluate the product's ability to assist the user to capture a LUS image with diagnostic quality. Percentage of zones with diagnostic image quality \> 0.80
- B-Lines DetectionUp to 24 weeks from completion of the study.
Evaluate the product's ability to retrospectively detect present B-lines on images acquired by a local expert with no Caption Lung AI assistance. AUROC \> 0.80; Sensitivity (Se) \> 0.80; Specificity (Sp) \> 0.75
- B-Line SignificanceUp to 24 weeks from completion of the study.
Evaluate the product's ability to retrospectively detect B-lines of significant severity on images acquired by a local expert with no Caption Lung AI assistance. AUROC \> 0.80; Sensitivity (Se) \> 0.80; Specificity (Sp) \> 0.75
- Remote Reader PerformanceUp to 24 weeks from completion of the study.
Evaluate the product's impact on a remote expert reader's ability to interpret LUS images. Difference Between Aided \& Unaided Groups: AUROC \> 0.00; Sensitivity (Se) \> 0.00; Specificity (Sp) \> 0.00