Cardiac Disease, Pulmonary DiseaseAIRFORCE2NCT06661200
Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique
A study testing SMC signal recording in people with Cardiac Disease, Pulmonary Disease and Healthy Volunteer, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease, Pulmonary Disease, Healthy Volunteer, Aortic Stenosis Disease
- What is being tested?
- SMC signal recording
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2024to 14 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique for Detecting Pulmonary and/or Cardiac
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.
Read more
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, Aortic Insufficiency, Systolic Dysfunction
- Being tested
- SMC signal recording
- Keywords
- ultrasound, surface motion camera, sismography
- Medical subject headings
- Heart Diseases, Lung Diseases, Mitral Valve Insufficiency, Aortic Valve Insufficiency, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMC signal recordingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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. Receives: 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% Receives: Device: SMC signal recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start17 May 2024
- Primary completion1 Jul 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Disease, Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661200
- Sponsor's protocol ID
- 2023-A02696-39
- Acronym
- AIRFORCE2
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 42417958
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique for Detecting Pulmonary and/or Cardiac
- ClinicalTrials.gov ID
- NCT06661200
- Acronym / sponsor ID
- AIRFORCE2 / 2023-A02696-39
- Conditions
- Cardiac Disease, Pulmonary Disease, Healthy Volunteer, Aortic Stenosis Disease, Mitral Regurgitation, Aortic Insufficiency, Systolic Dysfunction
- Keywords
- ultrasound, surface motion camera, sismography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects = no cardiac and no pulmonary disease | Experimental | Device: SMC signal recordingHealthy 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%. |
| Cardiac disease group | Experimental | Device: SMC signal recordingPatients 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. |
| Respiratory disease: | Experimental | Device: SMC signal recording(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% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMC signal recordingSMC 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. | Device | Cardiac disease group, Healthy subjects = no cardiac and no pulmonary disease, Respiratory disease: |
Primary outcome
Faisability to detect Surface Motion Camera (SMC) signal
Time frame: baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Derived from this study: PubMed 42417958Wintzenrieth 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMC signal recording in people with Cardiac Disease, Pulmonary Disease and Healthy Volunteer, run by University Hospital, Caen 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 9 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: finished, as of the sponsor's last update on 29 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faisability to detect Surface Motion Camera (SMC) signal (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06661200, which also lists 1 linked publication.
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 29 Jul 2026.