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DyspneaPAnDA-OneNCT07653204

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

An observational study of Dyspnea and Chest Pain, run by Austral Diagnostics at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyspnea, Chest Pain
What is being tested?
All patients from both groups will be imaged with airborne ultrasound device
Type of treatment
Medical device
How many people
2,500 participants
Where
1 siteFrance
Study dates
Sep 2026to May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Beatrice Spiluttini, PhD contact

0033603491582

clinical-investigation@australdx.fr

France1 site
  • La Pitié-Salpêtrière

    Paris, 75013

Other trials in France

About this study

Official title: Prospective Study for Data Acquisition in Emergency Departments to Develop a Discrimination Algorithm for the Origin of Dyspnea and Chest Pain Using the ADx-One Medical Device

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.

Read the detailed description

Acute dyspnea is a common reason for emergency department (ED) presentation, accounting for 7 to 12% of all consultations (Mockel et al., 2013). More than half of these patients are over 65 years of age - a population whose respiratory system is particularly vulnerable due to parenchymal degeneration and age-related decline in ventilatory and immune function (Boisguérin et Mauro, 2017). In the ED, the leading causes of acute dyspnea are acute heart failure, respiratory tract infections, exacerbations of asthma or chronic obstructive pulmonary disease, and pulmonary embolism (Ray et al., 2006). These episodes frequently lead to hospitalization and carry substantial mortality - reaching 10% in acute heart failure, for instance (Freund et al., 2020) - as well as a marked loss of autonomy, whether driven by the respiratory impairment itself or by the deconditioning that follows prolonged hospital stays.

Non-traumatic chest pain is another major reason for ED presentation, accounting for 5-10% of all visits, and shares with dyspnea the requirement for rapid etiological triage between life-threatening cardiovascular causes - acute coronary syndrome, pulmonary embolism, acute aortic syndrome, pericarditis, pneumothorax - and benign musculoskeletal or functional causes. Despite the ECG, high-sensitivity troponin and validated clinical scores, missed acute coronary syndrome at ED discharge has been reported in approximately 2% of patients (Pope et al., 2000), and the widespread use of "rule-out" strategies drives substantial use of coronary CTA and CT pulmonary angiography, with associated radiation exposure, costs and observation admissions. Diagnostic uncertainty is particularly pronounced in younger adults and in women, in whom the pretest probability of acute coronary syndrome is lower but pulmonary embolism, pneumothorax and pericarditis carry a non-negligible relative weight. Furthermore, several studies continue to highlight the increased use of irradiative imaging studies, with no clinical benefit in terms of diagnostic and prognostic (Roussel et al., 2023).

At present, the etiological work-up of acute dyspnea and chest pain relies on the combination of clinical examination, laboratory testing, and chest radiography (Olson et Davis, 2020; Miró et al., 2025). This strategy has well-documented limitations in the ED, particularly in older patients:

  • Clinical examination lacks discriminative power. Signs and symptoms are rarely disease-specific, and they may be blunted - or altogether absent - in the elderly (Metlay, Kapoor et Fine, 1997; Lien et al., 2002).
  • Chest radiography is often suboptimal. Films are frequently acquired with the patient supine, stooped, or unable to hold a full inspiration; the underlying parenchymal changes of ageing further compromise interpretation, and the radiographic signs themselves are notoriously nonspecific (Mueller-Lenke et al., 2006; Hawkins et al., 2009; Self et al., 2013).
  • Interpretation is poorly reproducible, and the initial ED diagnosis proves incorrect in nearly one third of cases (Hopstaken et al., 2004; Claessens et al., 2015).

ADx-One is an airborne ultrasound device which relies on Surface Motion Camera technology.

The ADx-One device is based on the non-invasive acquisition of minute chest surface movements induced by cardiopulmonary activity (~100 µm), using airborne ultrasound. These vibrations, resulting from mechanical interactions between the heart, lungs, and chest wall, constitute a physical signature that integrates multiple pathophysiological determinants (Shirkovskiy et al., 2018).

In particular, any modification in intrathoracic composition or mechanical properties-whether due to the presence of fluid (congestion, effusion), solid tissue changes (consolidation, atelectasis), or abnormal air presence (pneumothorax)-is likely to alter these vibratory signatures.

The overall purpose of this clinical investigation is to collect ADx-One acquisition data in emergency department patients in order to develop and evaluate on distinct cohorts a diagnostic support algorithm intended to assist discrimination of the origin of acute cardiopulmonary symptoms.

Conditions
Dyspnea, Chest Pain
Being tested
All patients from both groups will be imaged with airborne ultrasound device
Keywords
airborne ultrasound, dyspnea, chest pain, emergency department, algorithm
Medical subject headings
Dyspnea, Chest Pain, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • All patients from both groups will be imaged with airborne ultrasound deviceDevice

    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 groups in NCT07653204
Study groupRoleWhat they receive
training cohortAll patients will follow the same intervention but data from this cohort will only be used for training the algorithm.
Receives: Device: All patients from both groups will be imaged with airborne ultrasound device
Test CohortAll patients will follow the same intervention but data from this cohort will only be used for testing the algorithm.
Receives: Device: All patients from both groups will be imaged with airborne ultrasound device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within the first hour after ED admission.

Secondary outcomes (4)
  1. Number of correct assignations for acute heart failure with pulmonary edema by the algorithm.

    Diagnostic performance for the diagnosis of acute heart failure with pulmonary edema, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC

    Measured: Within the first hour after ED admission.

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

    Diagnostic performance for the diagnosis of chronic obstructive pulmonary disease, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.

    Measured: Within the first hour after ED admission.

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

    Diagnostic performance for the diagnosis of lower respiratory tract infection, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.

    Measured: Within the first hour after ED admission.

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

    Diagnostic performance for the diagnosis of absence of both pulmonary and cardiovascular involvement, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.

    Measured: Within the first hour after ED admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07653204
Sponsor's protocol ID
2026-A01025-46
Acronym
PAnDA-One
Status last verified
Jun 2026
First submitted
10 Jun 2026
Last updated
17 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Need to check this internally, also on IP.

Questions about this trial

What is this clinical trial studying?

An observational study of Dyspnea and Chest Pain, run by Austral Diagnostics at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Beatrice Spiluttini, PhD (0033603491582, clinical-investigation@australdx.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of correct assignations for cardiovascular involvement by the algorithm trained on labeled data. (time frame: Within the first hour after ED admission.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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