Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath

This is a prospective, non-randomized clinical validation research study. Subjects will consent and have two ultrasounds as part of the study.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Disease; Lung Ultrasound
• Intervention / Treatment: Device: Lung ultrasound

Detailed Description

This study is to collect data to validate the performance of Caption Lung AI in enabling trained healthcare professionals to perform LUS to obtain diagnostic-quality Lung Ultrasound Studies.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612-3833
      • Rush University Medical Center
    • Evanston, Illinois, United States, 60208
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Patients over the age of 22; AND
• 2. Patients with known lung pathology or patients with no known lung pathology in the hospital or presenting to the hospital or outpatient setting with shortness of breath.

Exclusion Criteria:

• 1. Patients in extremis and/or patients in whom a lung ultrasound would not normally be performed;
• 2. Patients who are unable to consent;
• 3. Patients who are prisoners; AND
• 4. Patients who do not speak English fluently.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 -Device 1; Cohort 1 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform an 8-zone lung ultrasound (LUS) exam. The Trained HCP will be required to capture at least 2 clips per zone using an ultrasound with Caption AI before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam). The Expert LUS user will use the same ultrasound system but without Caption Lung AI (Control Exam).	Device: Lung ultrasound; Lung ultrasound software.; Other Names: SaMD
Experimental: Cohort 2 -Device 2; Cohort 2 will utilize the Venue GO ultrasound system to perform a 12-zone lung ultrasound (LUS) exam. All Qualified users using Caption Lung AI will be required to capture at least 2 clips per zone before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam). The Qualified user will use the same ultrasound system but without Caption Lung AI (Control Exam).	Device: Lung ultrasound; Lung ultrasound software.; Other Names: SaMD
Active Comparator: Cohort 0 - Vscan (no AI); Cohort 0 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform the following lung ultrasound (LUS) exams.: Each patient will undergo 2 8-zone lung examinations which will be a combination of the enrollment distribution listed below equating to up to 30 subjects with 2 scans per subject (60 scans).	Device: Lung ultrasound; Lung ultrasound software.; Other Names: SaMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment	The primary endpoint will be based on the majority assessment of the independent expert readers qualitatively assessment of the LUS exam (study level) as being of diagnostic quality.	7 months
Cohort 2: % of patient studies composed of images acquired by the Qualified user to make a clinical assessment	The primary endpoint will be based on the majority assessment of the independent expert readers qualitatively assessment of the LUS exam (study level) as being of diagnostic quality.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1:	Sub-group analyses will be performed on the diagnostic image quality performance, with descriptive statistics reported based on age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, THCP, and zone of the image (1 - 8). The statistical analysis procedure and all applicable performance metrics that were used on the whole sample (i.e., the Primary Outcome Measures) will be repeated for each sub-group level. This will be conducted to ensure that there is no inherent bias where a specific sub-group level has a greater impact on the overall whole-sample performance compared to other levels.	7 months
Cohort 2:	Sub-group analyses will be performed on the diagnostic image quality performance, with descriptive statistics reported based on age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, THCP, and zone of the image (1 -12). The statistical analysis procedure and all applicable performance metrics that were used on the whole sample (i.e., the Primary Outcome Measures) will be repeated for each sub-group level. This will be conducted to ensure that there is no inherent bias where a specific sub-group level has a greater impact on the overall whole-sample performance compared to other levels.	7 months
Cohort 1:	Task-based comparison of the study and control exams: o Aided non-experts (i.e., THCP) and unaided experts (i.e., Expert LUS user) clips will be reviewed by expert readers for "normal" and "abnormal" ultrasound assessment at the zone level (B-lines, Pleural effusion, Non-aerated Lung / Consolidation, Lung Sliding).	7 months
Cohort 2:	Task-based comparison of the study and control exams: o Aided user and unaided user (i.e., Qualified user) clips will be reviewed by expert readers for "normal" and "abnormal" ultrasound assessment at the zone level (B-lines, Pleural effusion, Non-aerated Lung / Consolidation, Lung Sliding).	7 months
Cohort 1 and 2:	Recording mode (% of clips acquired with auto-capture rate versus save best clip).	7 months
Cohort 1:	Acquisition time to complete the LUS exam and for each view (1 - 8).	7 months
Cohort 2:	Acquisition time to complete the LUS exam and for each view (1 - 12).	7 months
Cohort 1 and 2:	Inter-rater (physician image-interpretation) variability.	7 months

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Northwestern University; Yale University; Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 6, 2025
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Actual): July 1, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Lung Ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: SA-000147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No