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

Not Applicable

Not yet recruiting

• Conditions: Lung Disease; Lung Ultrasound

• Registration Number: NCT07046234
• Lead Sponsor: GE Healthcare

Brief Summary

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

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 Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment	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.
Cohort 2: % of patient studies composed of images acquired by the Qualified user to make a clinical assessment	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 Outcome Measures

Name	Time	Method
Cohort 1:	7 months	Acquisition time to complete the LUS exam and for each view (1 - 8).
Cohort 2:	7 months	Acquisition time to complete the LUS exam and for each view (1 - 12).
Cohort 1 and 2:	7 months	Inter-rater (physician image-interpretation) variability.

Trial Locations

Locations (3)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States