A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caption LungAI.
- Who it may be relevant to
- Registry conditions: Shortness of Breath. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of this study is to assess the efficacy of Caption LungAI.
Detailed description
After being informed about the study, all patients giving written informed consent will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and one exam conducted by a (non-expert) healthcare provider who is trained on Caption LungAI and will use Caption LungAI to capture images.
Interventions
- Device Caption LungAI
Caption LungAI is a software that is designed to help non-expert healthcare professionals acquire diagnostic quality images on an 8-zone lung protocol for both healthy patients and patients presenting with pathology such as B-Lines.
Primary outcome measures
- Diagnostic Image Quality (Trained Healthcare Professional) [Time frame: Up to 24 weeks from completion of the study.]
- B-Lines Detection [Time frame: Up to 24 weeks from completion of the study.]
- B-Line Significance [Time frame: Up to 24 weeks from completion of the study.]
- Remote Reader Performance [Time frame: Up to 24 weeks from completion of the study.]
Secondary outcome measures (1)
- Sub-group Analyses [Time frame: Up to 24 weeks from completion of the study.]
Eligibility criteria
Inclusion criteria
- Patients over the age of 18
- Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines.
Exclusion criteria
- Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 4 centers
- Yale New Haven Hospital — New Haven
- Northwestern University — Chicago
- Rush University Medical Center — Chicago
- The Moses H. Cone Memorial Hospital — Greensboro
Publications
- Baloescu C, Bailitz J, Cheema B, Agarwala R, Jankowski M, Eke O, Liu R, Nomura J, Stolz L, Gargani L, Alkan E, Wellman T, Parajuli N, Marra A, Thomas Y, Patel D, Schraft E, O'Brien J, Moore CL, Gottlieb M. Artificial Intelligence-Guided Lung Ultrasound by Nonexperts. JAMA Cardiol. 2025 Mar 1;10(3):245-253. doi: 10.1001/jamacardio.2024.4991. PMID 39813064
Identifiers
NCT: NCT05992324 · LungPivotal