The purpose of this study is to assess the efficacy of Caption LungAI.
After being informed about the study, all patients giving written informed consent will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and one exam conducted by a (non-expert) healthcare provider who is trained on Caption LungAI and will use Caption LungAI to capture images.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
220
Caption LungAI is a software that is designed to help non-expert healthcare professionals acquire diagnostic quality images on an 8-zone lung protocol for both healthy patients and patients presenting with pathology such as B-Lines.
Yale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
COMPLETEDRush University Medical Center
Chicago, Illinois, United States
COMPLETEDDiagnostic Image Quality (Trained Healthcare Professional)
Evaluate the product's ability to assist the user to capture a LUS image with diagnostic quality. Percentage of zones with diagnostic image quality \> 0.80
Time frame: Up to 24 weeks from completion of the study.
B-Lines Detection
Evaluate the product's ability to retrospectively detect present B-lines on images acquired by a local expert with no Caption Lung AI assistance. AUROC \> 0.80; Sensitivity (Se) \> 0.80; Specificity (Sp) \> 0.75
Time frame: Up to 24 weeks from completion of the study.
B-Line Significance
Evaluate the product's ability to retrospectively detect B-lines of significant severity on images acquired by a local expert with no Caption Lung AI assistance. AUROC \> 0.80; Sensitivity (Se) \> 0.80; Specificity (Sp) \> 0.75
Time frame: Up to 24 weeks from completion of the study.
Remote Reader Performance
Evaluate the product's impact on a remote expert reader's ability to interpret LUS images. Difference Between Aided \& Unaided Groups: AUROC \> 0.00; Sensitivity (Se) \> 0.00; Specificity (Sp) \> 0.00
Time frame: Up to 24 weeks from completion of the study.
Sub-group Analyses
The following sub-group analyses will be performed for the primary endpoints: age (\< 65, ≥ 65), BMI group (\< 25, 25 ≤ BMI \< 30, ≥ 30), gender (Male / Female), site location, trained HCP, and zone of the image (1 - 8).
Time frame: Up to 24 weeks from completion of the study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
COMPLETED