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Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain (PAnDA-One)

2026年6月15日 更新者:Austral Diagnostics

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

2500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Paris、法国、75013
        • La Pitié-Salpétrière

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
training cohort
All patients will follow the same intervention but data from this cohort will only be used for training the algorithm.
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
All patients will follow the same intervention but data from this cohort will only be used for testing the algorithm.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of correct assignations for cardiovascular involvement by the algorithm trained on labeled data.
大体时间: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.
Within the first hour after ED admission.

次要结果测量

结果测量
措施说明
大体时间
Number of correct assignations for acute heart failure with pulmonary edema by the algorithm.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of acute heart failure with pulmonary edema, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC
Within the first hour after ED admission.
Number of correct assignations for COPD exacerbation by the algorithm.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of chronic obstructive pulmonary disease, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
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.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of lower respiratory tract infection, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for absence of pulmonary and cardiovascular involvement.
大体时间:Within the first hour after ED admission.
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.
Within the first hour after ED admission.

其他结果措施

结果测量
措施说明
大体时间
Number of correct assignations by the algorithm for pulmonary involvement, either isolated or combined with cardiovascular involvement.
大体时间:Within the first hour after ED admission.
Diagnostic performance for distinguishing pulmonary from non-pulmonary involvement, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC. Pulmonary involvement is defined as any diagnosis of pulmonary or parenchymal lesion or bronchial involvement, including (but not limited to): upper respiratory tract infection, lower respiratory tract infection, exacerbation of obstructive ventilatory disorder such as asthma or COPD.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for lung interstitial syndrome.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of interstitial syndrome, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for detecting an impaired left ventricular ejection fraction.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of a left ventricular ejection fraction < 55% at cardiac echography at any point in the month before or after the inclusion, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for pulmonary embolism.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of pulmonary embolism, diagnosed either at computed tomography pulmonary angiogram or V/Q scan, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for upper respiratory tract infection.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of upper respiratory tract infection, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for atelectasis.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of atelectasis, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for alveolar syndrome.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of alveolar syndrome, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for pleural effusion.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of pleural effusion, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC.
Within the first hour after ED admission.
Number of correct assignations by the algorithm for pneumothorax.
大体时间:Within the first hour after ED admission.
Diagnostic performance for the diagnosis of pneumothorax, including sensitivity, specificity, positive and negative predictive values, likelihood ratios, and AUROC
Within the first hour after ED admission.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yonathan Freund, Professor、Assistance Publique - Hôpitaux de Paris

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Need to check this internally, also on IP.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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