Clinical Validation of Tele-stethoscope System Digital

Study Overview
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Brief Summary
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Acute respiratory infections and other respiratory and cardiology diseases like COPD or heart failure are important causes of morbidity and mortality around the world. Telemedicine is defined as the delivery of health care and the sharing of medical knoledge over distances using telecommunication systems. Inexpensive techologies offer the possibility of a direct, real-time connection between the patient or the other end. These technologies help to the physicians to manage different symptoms and cardio-respiratory diseases. A real-time wireless tele-stethoscopy system was designed to allow a physician to receive real-time cardio-respiratory sounds from a remote auscultation, as well as video images showing where the technician is placing the stethoscope on the patient´s body. Actually, the lack of physicians in rural areas of developing countries makes difficult their correct diagnosis and treatment. Furthermore, in the majority of health systems, the patients are shared between primary care and medical specialty in hospitals. The tele-stethoscopy system through telemedicine could help to the physicians or health-care technicians in the majority of health systems and especially in rural areas of developing countries without physicians to manage the patients. For this reason, the goal of this project is the clinical validation of an open real-time tele-stethoscope systme (EHAS-Fundatel digital stethoscope) previously designed, with different specialist (pneumologists, cardiologists and internists.)

Official Title
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Clinical Validation of Tele-stethoscope System Digital Bluetooth Ehas-fundatel

Conditions
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Respiratory Disorder, Heart Disorder

Intervention / Treatment
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* Device: Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent sign. Pacient admitted to hospital with any disease but no inestable disease. Exclusion Criteria: The lack of informed consent. Inestable disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: An open real-time tele-stethoscopy system<br>EHAS-Fundatel digital stethoscope is an open real-time tele-stethoscopy system. The interventions in this arm will be to make a respiratory and heart auscultation with this tele-stethoscope. After that, we will do the comparison or agreetment between the auscultation of two protocols: tele-stethoscopy system and conventional stethoscope. | Device: Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)<br>* We compare the respiratory and heart auscultation of clinicians using the EHAS-Fundatel digital stethoscope and a conventional stethoscope and we will observe; inter-observer and intra-observer differences by two auscultation methods.<br>|
| Active Comparator: Conventional stethoscope<br>Conventional stethoscope used is the 3M Littmann Classic II S.E. stethoscope. The interventions in this arm will be to make a respiratory and heart auscultation with this conventional stethoscope. After that we will do the comparison or agreetment between the ascultation of two protocols: conventional stethoscope and tele-stethoscopy system. | Device: Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)<br>* We compare the respiratory and heart auscultation of clinicians using the EHAS-Fundatel digital stethoscope and a conventional stethoscope and we will observe; inter-observer and intra-observer differences by two auscultation methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-observer agreement for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope) | The investigators will randomize the first auscultation (baseline auscultation) into tele-stethoscope system or conventional stethoscope. After 1 hour, we will use the other auscultation method. The investigators will measure if there is a heart murmur or not and the intra-observer agreement by the kappa index in the heart murmurs auscultation. | change from baseline auscultation to final auscultation (after 1 hour) | 
| Intra-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope) | The investigators will measure if there is a heart rhythm auscultation or not rhythm and the intra-observer agreement by the kappa index in the heart rhythm auscultation. | change from baseline auscultation to final auscultation (after 1 hour) | 
| Intra-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope) | The investigators will measure if there is a normal vesicular murmur or not and the intra-observer agreement by the kappa index in the vesicular murmur auscultation. | change from baseline auscultation to final auscultation (after 1 hour) | 
| Intra-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope) | The investigators will measure if there is a lung rale sound or not and the intra-observer agreement by the kappa index in the lung rale sound. | change from baseline auscultation to final auscultation (after 1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-observer agreement for for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope) | The investigators will randomize the first auscultation (baseline auscultation) into tele-stethoscope system or conventional stethoscope. After 1 hour, we will use the other auscultation method. The investigators will measure if there is a heart murmur or not and the inter-observer agreement by the kappa index in the heart murmurs auscultation. | change from baseline auscultation to final auscultation (after 1 hour) | 
| Inter-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope) | The investigators will measure if there is a heart rhythm auscultation or not rhythm and the inter-observer agreement by the kappa index in the heart rhythm auscultation. | change from baseline auscultation to final auscultation (after 1 hour) | 
| Inter-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope) | The investigators will measure if there is a normal vesicular murmur or not and the inter-observer agreement by the kappa index in the vesicular murmur auscultation. | change from baseline auscultation to final auscultation (after 1 hour) | 
| Inter-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope) | The investigators will measure if there is a lung rale sound or not and the inter-observer agreement by the kappa index in the lung rale sound. | change from baseline auscultation to final auscultation (after 1 hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicina, Respiratory sounds, Tele-stethoscopy, Wireless, Real-time, e-health, Heart sounds