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: Recruiting
• Conditions: Cardiac Disease, Pulmonary Disease
• Intervention / Treatment: Device: SMC signal recording

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric SALOUX, MD; Phone Number: +33 02 31 06 44 12; Email: saloux-e@chu-caen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subjects N = 70 no cardiac and no pulmonary disease; Healthy subjects who should undergo SMC recording after echocardiography and resporatory exploration.	Device: SMC 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.
Experimental: Cardiac disease group; Patients in this group had heart disease (n = 150): (i) aortic stenosis (ii) aortic leakage (iii) mitral leakage (iv) dilated cardimyopathy (v) or restrictive cardiomyopathy.	Device: SMC 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.
Experimental: Respiratory failure	Device: SMC 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): February 14, 2025
• Study Completion (Estimated): February 14, 2026

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound, surface motion camera, sismography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Diseases
• Other Study ID Numbers: 2023-A02696-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No