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

General Electric (GE)

Status: Not yet enrolling

Conditions: Lung Ultrasound; Lung Disease

Treatments: Device: Lung ultrasound

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07046234

SA-000147

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Cohort 1 -Device 1

Experimental group

Description:

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).

Treatment:

Device: Lung ultrasound

Cohort 2 -Device 2

Experimental group

Description:

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).

Treatment:

Device: Lung ultrasound