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临床试验/NCT06661200
NCT06661200已完成不适用

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

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
270
试验地点
1
主要终点
Surface Motion Camera (SMC) signal

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: SMC signal recording (Device)

结局指标

主要结局

Surface Motion Camera (SMC) signal

时间窗: 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

Faisability to detect Surface Motion Camera (SMC) signal

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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