Status:
COMPLETED
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Pleural Effusion
Lung Consolidation
Eligibility:
All Genders
Brief Summary
This study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion. The information will be used t...
Detailed Description
This is a prospective, observational, multi-center, post-market clinical study. Enrollment will continue (up to a maximum of 500 adult subjects and up to 300 pediatric subjects) until diagnostic LUS e...
Eligibility Criteria
Inclusion
- Subjects presenting to the Emergency Department, admitted to the hospital, or seen in the outpatient setting with suspicion of pleural effusion or lung consolidation who received chest imaging to include chest X-ray or CT, or for whom chest X-ray or CT are planned.
- Suspicion of pleural effusion or lung consolidation may be based upon imaging findings or presentation of symptoms including (but not limited to) dyspnea, hypoxia, tachypnea, rales, or dullness.
- All attempts should be made for subjects to undergo scanning of 14 lung zones (adults) and 12 lung zones (pediatrics). Attempts should also be made to capture all required lung zones in adults and pediatrics. Instances where all zones cannot be captured need to be documented and reason for inability to scan them provided in EDC. See Section 8.1.3 Lung Ultrasound Exams.
- Subject is willing to provide informed consent (or assent where age appropriate) to participate in the study. Subjects under 18 years of age require informed consent of a parent or guardian and assent as required by institutional IRB.
- Weight of subject is greater than or equal to 10 kg.
Exclusion
- Subject has pathology precluding safe and pain-free ultrasound probe placement such as burn, significant soft tissue injury or surgical incisions.
- Current imprisonment.
- Pregnancy (self-reported)
- Subjects with breast implants
- Prior pleurodesis procedure.
- History of severe lung disease and home oxygen use
- Presence of subcutaneous air that precludes imaging
- Body Mass Index (BMI) \> 40
- Significant scoliosis (Cobb angle ≥ 20 degrees).
- Pediatric subjects with chronic lung diseases other than asthma.
- Pediatric subjects on chronic respiratory support (i.e., nasal canula, CPAP, BiPAP, or tracheostomy).
Key Trial Info
Start Date :
September 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT04891705
Start Date
September 11 2021
End Date
December 14 2023
Last Update
December 15 2023
Active Locations (5)
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1
Arizona Emergency Medical Research Center
Tucson, Arizona, United States, 85724
2
University of Colorado Hospital
Aurora, Colorado, United States, 80045
3
Yale School of Medicine
New Haven, Connecticut, United States, 06510
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215