Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study (AI)

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 to test the performance of Artificial Intelligence (AI) in identification of features associated with the above lung conditions.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion; Lung Consolidation
• Intervention / Treatment: Device: Lung Ultrasound Scan

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 exams are acquired for each of the following groups:

Approximately 500 Adult subjects targeting:

• Approximately 175 exams from patients positive for lung consolidation
• Approximately 175 exams from patients positive for pleural effusion
• Approximately 150 exams from patients negative for both conditions

Approximately 300 pediatric subjects targeting:

• Approximately 150 exams from patients positive for lung consolidation
• Approximately 150 exams from patients negative for lung consolidation

• Study Type: Observational
• Enrollment (Actual): 554

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Arizona Emergency Medical Research Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Greenville Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with suspicion of pleural effusion or lung consolidation will be enrolled in the study. In addition, pediatric subjects with suspicion of lung consolidation (with weight of at least 10 kg) will be enrolled.

Description

Inclusion Criteria:

1. 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.

2. 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.
3. 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.
4. Weight of subject is greater than or equal to 10 kg.

Exclusion Criteria:

1. Subject has pathology precluding safe and pain-free ultrasound probe placement such as burn, significant soft tissue injury or surgical incisions.
2. Current imprisonment.
3. Pregnancy (self-reported)
4. Subjects with breast implants
5. Prior pleurodesis procedure.
6. History of severe lung disease and home oxygen use
7. Presence of subcutaneous air that precludes imaging
8. Body Mass Index (BMI) > 40
9. Significant scoliosis (Cobb angle ≥ 20 degrees).
10. Pediatric subjects with chronic lung diseases other than asthma.
11. Pediatric subjects on chronic respiratory support (i.e., nasal canula, CPAP, BiPAP, or tracheostomy).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pleural Effusion; Adult and pediatric subjects with suspicion of pleural effusion	Device: Lung Ultrasound Scan; Ultrasound scan of subjects in up to 14 lung zones
Lung Consolidation; Adult and pediatric subjects with suspicion of lung consolidation	Device: Lung Ultrasound Scan; Ultrasound scan of subjects in up to 14 lung zones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The study data will be used to support future performance assessments for Artificial Intelligence based algorithms as described by FDA guidance for Computer Assisted Detection and Diagnostic Devices	Discharge up to 30 days (Single visit)

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Study Director: Jochen Kruecker, Philips Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2021
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Diagnostics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: US-Lung AI-11237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes