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Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique

Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique for Detecting Pulmonary and/or Cardiac

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06661200
Acronym
AIRFORCE2
Enrollment
270
Registered
2024-10-28
Start date
2024-05-17
Completion date
2025-08-14
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Insufficiency, Aortic Stenosis Disease, Cardiac Disease, Pulmonary Disease, Diastolic Dysfunction, Healthy Volunteer, Mitral Regurgitation, Pulmonary Insufficiency, Systolic Dysfunction

Keywords

ultrasound, surface motion camera, sismography

Brief summary

Heart and lung disease are two major causes of hospitalisation and mortality in France (4-8). Together, these two diseases affect several million people in France, either acutely or chronically. They represent a major public health problem in social and economic terms. Diagnosis of these disorders is often delayed, with acute decompensation preceded by a period of frustrating, non-specific clinical signs (9-12), which delay their discovery. Screening for these conditions in their early stages or diagnosing them in their acute form is crucial, but remains difficult because it requires multiple investigations that are costly and time-consuming (biology, radiology, ECG, etc.). The difficulty of diagnosis, the progressive profile and the ever-increasing frequency of these conditions (environmental and socio-economic factors) have considerably altered the landscape of medical emergencies and contributed to their difficulty. The availability of a non-invasive technique capable of diagnosing both cardiac and pulmonary disorders without the help of an expert, without direct contact with the patient and without requiring his or her active participation, would be a major advance. Technological innovations in all fields have always helped to improve patient care.The recent emergence of telemedicine and POCT(US) connected objects (point of care testing, point of care ultrasound)(13,14) is a good illustration of this. A new technique using ultrasound, developed by the Langevin Institute (Surface Camera Motion) and supported by the start-up Austral Diagnostics, makes it possible, without direct contact with the subject, to record the propagation of thoracic vibrations induced by the functioning of the heart pump and respiratory mechanics.Consequently, any anomaly in the functioning of these organs can cause a change in the thoracic vibration regime and its propagation. This completely new technique for exploring thoracic vibrations provides a particularly rich signal that has not yet been explored. Under these conditions, the signatures associated with cardiac and/or pulmonary pathologies are not yet perfectly defined.Furthermore, the diagnostic potential of this new technique in the early or acute phases of cardiopulmonary pathologies remains to be assessed. In this prospective study, we propose to explore the signatures produced by this signal in various cardiac and respiratory pathologies. The aim is To identify the discriminating criteria of the SMC signal that enable cardiac and pulmonary pathologies to be detected compared with a group of healthy subjects.

Interventions

DEVICESMC signal recording

SMC recording involves collecting vibrations from the thorax using an antenna equipped with piezoelectric crystals. Subjects face the machine or stand with their backs to the machine, shirtless. Acquisitions last around ten seconds.

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

First in Man diagnostic performance, monocentric, open, comparative, cross-sectional, made up of three groups: * cardiopathies (150 subjects) * healthy subjects (30 subjects) * pulmonary diseases (90 subjects)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Cardiac disease OR respiratory failure OR healthy volunteer * Affiliate to the social security system * French-speaking * Patient having been informed of the study and having signed informed

Exclusion criteria

* consent.BMI \< 17 or BMI \> 35 * Patients unable to stand for more than 10 minutes * Patients unable to remain in apnea for 15 - 20 seconds * Breast prosthesis wearers * Wearers of pacemakers and/or defibrillators * Valve prosthesis wearers * Patients with difficulty understanding simple instructions (inspiration, expiration, respiratory blockage) * Patients with severe hearing problems. * Pregnant or breastfeeding woman. A urine pregnancy test will be performed if necessary.

Design outcomes

Primary

MeasureTime frameDescription
Faisability to detect Surface Motion Camera (SMC) signalbaselineIdentify the discriminating criteria of the SMC signal allowing the detection of cardiac pathologies on the one hand and pulmonary pathologies on the other hand versus a group of healthy subjects

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026