All patients from both groups will be imaged with airborne ultrasound device
All patients from both groups will be imaged with airborne ultrasound device: Patients from both cohorts will follow their usual routine, except for stepping in front of the machine so that one or two images of their chest and back can be taken.
Study summary
PAnDA-One is a prospective, multicenter, interventional study (10 centers, France) aimed at developing and validating a diagnostic support algorithm based on the ADx-One medical device, which non-invasively acquires thoracic vibrations using airborne ultrasound.
The study will enroll 2,500 patients presenting to the emergency department with acute dyspnea or non-traumatic chest pain, divided into a development cohort (N = 1,500) and an independent test cohort (N = 1,000). The deep learning algorithm will be trained to discriminate cardiovascular from non-cardiovascular origins of symptoms, and its performance will be assessed by AUROC, sensitivity, and specificity against a final diagnosis established by an expert adjudication committee.
Patient management will not be modified by study participation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Presentation to the emergency department for one or more of the following symptoms of less than 14 days' duration: acute non-traumatic dyspnea, or recent worsening of chronic dyspnea, or non-traumatic chest pain.
* Patient able to sit on a chair or on the edge of the bed
* Affiliation to national health insurance
* Able to receive study information, understand the study, and provide written informed consent
Exclusion Criteria:
* • Immediate need for life-saving intervention or clinical instability incompatible with study procedures.
* Shock or severe hemodynamic instability, for example systolic blood pressure \<90 mmHg for at least 30 minutes or associated signs of hypoperfusion.
* Altered mental status or any condition preventing provision of valid informed consent.
* Known cognitive impairment preventing informed consent.
* Transfer to another care site before the ADx-One acquisition can be performed.
* Known pregnancy
* Minor, legally protected adult, or person deprived of liberty.
* Participation in another interventional clinical study judged incompatible with this study.
Primary outcome measure(s)
Number of correct assignations for cardiovascular involvement by the algorithm trained on labeled data. — Within the first hour after ED admission. Diagnostic performance for distinguishing cardiovascular from non-cardiovascular involvement, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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