Shortness of Breath
Conditions
Keywords
Lung Ultrasound, B-Lines, POCUS by non-expert user
Brief summary
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
DEVICECaption 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.
Sponsors
Caption Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| B-Line Significance | Up 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 Performance | Up 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 |
| 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 Detection | Up 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sub-group Analyses | Up to 24 weeks from completion of the study. | 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). |
Countries
United States
Contacts
Primary ContactAngeline Trinidad
Outcome results
None listed