Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAustral Diagnostics
About this trial
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
Qualifiers
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
Disqualifiers
• 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.
Trial design
Treatments tested in this trial
- All patients from both groups will be imaged with airborne ultrasound device
Treatment groups
2,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov