A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of Caption LungAI.

Detailed Description
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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.

Official Title
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A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation

Conditions
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Shortness of Breath

Intervention / Treatment
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* Device: Caption LungAI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients presenting with clinical suspicion of B-Lines<br>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. | Device: Caption LungAI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-Lines, Lung Ultrasound, POCUS by non-expert user