Evaluating a new lung ultrasound technology for shortness of breath
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
This study is testing a new AI tool to see if it helps non-experts do better lung ultrasound exams for patients who have shortness of breath.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Caption Health, Inc. Industry-sponsored |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Trial ID | NCT05992324 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of Caption LungAI in performing lung ultrasound exams. Participants will undergo two separate lung ultrasound exams: one conducted by an expert without the aid of Caption LungAI and another by a trained non-expert using the technology. The goal is to determine how well the non-expert can capture and interpret lung images with the assistance of this AI tool. The study focuses on patients presenting with shortness of breath and suspected B-lines.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old experiencing shortness of breath and suspected to have B-lines.
Not a fit: Patients in critical condition where a lung ultrasound would not typically be performed will not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could enable non-expert healthcare providers to accurately assess lung conditions, improving patient care and outcomes.
How similar studies have performed: Other studies have shown promise in using AI-assisted imaging technologies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut and 3 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Completed)
- Rush University Medical Center — Chicago, Illinois, United States (Completed)
- The Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States (Completed)
Study contacts
- Study coordinator: Angeline Trinidad
- Email: angeline.trinidad@gehealthcare.com
- Phone: 619-322-0727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.