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NCT07653204
Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain
Conditions: Dyspnea, Chest Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 2500
Sponsor: Austral Diagnostics
Location: La Pitié-Salpêtrière Paris
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07653204). StuddyBuddy aggregates publicly available trial information.