Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique (AIRFORCE2)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Caen, France
- Caen University hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Healthy subjects = no cardiac and no pulmonary disease
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%. |
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.
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Experimental: Cardiac disease group
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.
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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.
|
|
Experimental: Respiratory disease:
(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%
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Faisability to detect Surface Motion Camera (SMC) signal
Time Frame: baseline
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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
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baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A02696-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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