Menu
Enrolling by invitation NCT07046234

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

No phase Interventional Lung Disease Lung Ultrasound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lung ultrasound.
Who it may be relevant to
Registry conditions: Lung Disease, Lung Ultrasound. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Lung ultrasound
    Lung ultrasound software.

Primary outcome measures

  • Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment [Time frame: 7 months]
  • Cohort 2: % of patient studies composed of images acquired by the Qualified user to make a clinical assessment [Time frame: 7 months]
Secondary outcome measures (8)
  • Cohort 1: [Time frame: 7 months]
  • Cohort 2: [Time frame: 7 months]
  • Cohort 1: [Time frame: 7 months]
  • Cohort 2: [Time frame: 7 months]
  • Cohort 1 and 2: [Time frame: 7 months]
  • Cohort 1: [Time frame: 7 months]
  • Cohort 2: [Time frame: 7 months]
  • Cohort 1 and 2: [Time frame: 7 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 3 centers
  • Yale University School of Medicine — New Haven
  • Rush University Medical Center — Chicago
  • Northwestern University — Evanston

Identifiers

NCT: NCT07046234 · SA-000147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗