Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain

NCT07653204 | Not Yet Recruiting

• 1 other identifier: 2026-A01025-46
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyspnea; Chest Pain

Keywords

airborne ultrasound; dyspnea; chest pain; emergency department; algorithm

Outcome Measures

Primary Outcomes (1)

• Number of correct assignations for cardiovascular involvement by the algorithm trained on labeled data.

  Diagnostic performance for distinguishing cardiovascular from non-cardiovascular involvement, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.

  Within the first hour after ED admission.

Secondary Outcomes (4)

• Number of correct assignations for acute heart failure with pulmonary edema by the algorithm.

  Within the first hour after ED admission.

• Number of correct assignations for COPD exacerbation by the algorithm.

  Within the first hour after ED admission.

• Number of correct assignations by the algorithm for lower respiratory tract infection, defined as alveolar or interstitial involvement from an infectious cause.

  Within the first hour after ED admission.

• Number of correct assignations by the algorithm for absence of pulmonary and cardiovascular involvement.

  Within the first hour after ED admission.

Other Outcomes (9)

• Number of correct assignations by the algorithm for pulmonary involvement, either isolated or combined with cardiovascular involvement.

  Within the first hour after ED admission.

• Number of correct assignations by the algorithm for lung interstitial syndrome.

  Within the first hour after ED admission.

• Number of correct assignations by the algorithm for detecting an impaired left ventricular ejection fraction.

  Within the first hour after ED admission.

Study Arms (2)

training cohort

All patients will follow the same intervention but data from this cohort will only be used for training the algorithm.

Device: All patients from both groups will be imaged with airborne ultrasound device

Test Cohort

All patients will follow the same intervention but data from this cohort will only be used for testing the algorithm.

Device: All patients from both groups will be imaged with airborne ultrasound device

Interventions

All patients from both groups will be imaged with airborne ultrasound device 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.

Test Cohort; training cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Austral Diagnostics: lead

Study Sites (1)

La Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Dyspnea; Chest Pain; Emergencies

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Disease Attributes; Pathologic Processes

Study Officials

• Yonathan Freund, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatrice Spiluttini, PhD

CONTACT

0033603491582; clinical-investigation@australdx.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FR (1)