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

NCT06661200 | Completed

• 1 other identifier: 2023-A02696-39
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ultrasound, surface motion camera, sismography

Outcome Measures

Primary Outcomes (1)

• Faisability to detect Surface Motion Camera (SMC) signal

  Identify 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

  baseline

Study Arms (3)

Healthy subjects = no cardiac and no pulmonary disease

EXPERIMENTAL

Healthy subjects who should undergo SMC recording after echocardiography and resporatory exploration. The volunteers do not show any detectable cardiac damage on ultrasound (ejection fraction \>= 50%, no diastolic dysfunction and no structural disease) or any detectable pulmonary damage on ventilatory tests (Forced expiratory volume in the first second (FEV1), diffusing capacity of the lungs for carbon monoxide (DLCO) and total lung capacity (TLC) ≥ 80%) , FEV1/forced vital capacity (FVC) ratio ≥ 70%.

Device: SMC signal recording

Cardiac disease group

EXPERIMENTAL

Patients in this group had heart disease: (i) moderate to severe aortic stenosis (ii) moderate to severe aortic regurgitation (iii) moderate to severe mitral regurgitation (iv) systolic dysfunction (v) or diastolic dysfunction.

Device: SMC signal recording

Respiratory disease:

EXPERIMENTAL

(i) Patients with no pulmonary insufficiency : forced expiratory volume in one second (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO) and total lung capacity (TLC) ≥ 80% (ii) Patients with moderate pulmonary insufficiency : forced expiratory volume in one second (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO) and total lung capacity (TLC) ≥ 50% and \< 80% (iii) Patients with severe forced expiratory volume in one second (FEV1) or diffusing capacity of the lungs for carbon monoxide (DLCO) or total lung capacity (TLC)\< 50%

Device: SMC signal recording

Interventions

SMC signal recording DEVICE

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.

Cardiac disease group; Healthy subjects = no cardiac and no pulmonary disease; Respiratory disease:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

Location

Related Publications (1)

• Wintzenrieth F, Couade M, Mouadil A, Saloux E, Fink M, Ing RK, Bayat S. Airborne Ultrasound Surface Motion Camera: Application to Transfer Admittance Chest Imaging. Ann Biomed Eng. 2026 Jul 8. doi: 10.1007/s10439-026-04252-0. Online ahead of print.

  PMID: 42417958 DERIVED

MeSH Terms

Conditions

Heart Diseases; Lung Diseases; Mitral Valve Insufficiency; Aortic Valve Insufficiency; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases; Heart Valve Diseases; Aortic Valve Disease; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 28, 2024
• Study Start: May 17, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 14, 2025
• Last Updated: July 29, 2026

Record last verified: 2025-01

Locations

FR (1)