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Enrolling by Invitation

NCT Number: NCT07046234

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.

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Key information

Conditions

Lung Disease Lung Diseases Lung Ultrasound Respiratory Tract Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung ultrasound

Device

Lung ultrasound software.

Other names: SaMD

Primary outcomes

  1. Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment

    Time frame: 7 months

    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.

  2. Cohort 2: % of patient studies composed of images acquired by the Qualified user to make a clinical assessment

    Time frame: 7 months

    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.

Secondary outcomes

  1. Cohort 1:

    Time frame: 7 months

    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.

  2. Cohort 2:

    Time frame: 7 months

    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.

  3. Cohort 1:

    Time frame: 7 months

    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).

  4. Cohort 2:

    Time frame: 7 months

    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).

  5. Cohort 1 and 2:

    Time frame: 7 months

    Recording mode (% of clips acquired with auto-capture rate versus save best clip).

  6. Cohort 1:

    Time frame: 7 months

    Acquisition time to complete the LUS exam and for each view (1 - 8).

  7. Cohort 2:

    Time frame: 7 months

    Acquisition time to complete the LUS exam and for each view (1 - 12).

  8. Cohort 1 and 2:

    Time frame: 7 months

    Inter-rater (physician image-interpretation) variability.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Northwestern University
  • Rush University Medical Center
  • Yale University

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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