A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Purpose
The purpose of this study is to assess the efficacy of Caption LungAI.
Condition
- Shortness of Breath
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Patients presenting with clinical suspicion of B-Lines |
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. |
|
Recruiting Locations
Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06510
New Haven 4839366, Connecticut 4831725 06510
More Details
- NCT ID
- NCT05992324
- Status
- Recruiting
- Sponsor
- Caption Health, Inc.
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.