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The purpose of this study is to assess the efficacy of Caption LungAI.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients presenting with clinical suspicion of B-Lines | Experimental | Patients will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and will last approximately 5-10 minutes. The second exam will be conducted by a healthcare professional with Caption LungAI and will last approximately 15-20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caption LungAI | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Image Quality (Trained Healthcare Professional) | 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 | Up to 24 weeks from completion of the study. |
| B-Lines Detection | 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 | Up to 24 weeks from completion of the study. |
| B-Line Significance | 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 | Up to 24 weeks from completion of the study. |
| Remote Reader Performance | 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 | Up to 24 weeks from completion of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Sub-group Analyses | The following sub-group analyses will be performed for the primary endpoints: age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, trained HCP, and zone of the image (1 - 8). | Up to 24 weeks from completion of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angeline Trinidad | Contact | 619-322-0727 | angeline.trinidad@gehealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39813064 | Derived | 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. |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Northwestern University | Completed | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Completed | Chicago | Illinois | 60612 | United States |
| The Moses H. Cone Memorial Hospital | Completed | Greensboro | North Carolina | 27401 | United States |
| D013568 | Pathological Conditions, Signs and Symptoms |