Clinical Validation of Tele-stethoscope System Digital

Not Applicable

Completed

• Conditions: Respiratory Disorder; Heart Disorder
• Interventions: Device: Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)

• Registration Number: NCT03596541
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief Summary

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.)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Study Start: 2018-08-27
• Primary Completion: 2018-11-27
• Study Completion: 2018-12-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
An open real-time tele-stethoscopy system	Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)	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.
Conventional stethoscope	Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)	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.

Primary Outcome Measures

Name	Time	Method
Intra-observer agreement for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)	change from baseline auscultation to final auscultation (after 1 hour)	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.
Intra-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)	change from baseline auscultation to final auscultation (after 1 hour)	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.
Intra-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)	change from baseline auscultation to final auscultation (after 1 hour)	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.
Intra-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)	change from baseline auscultation to final auscultation (after 1 hour)	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.

Secondary Outcome Measures

Name	Time	Method
Inter-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)	change from baseline auscultation to final auscultation (after 1 hour)	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.
Inter-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)	change from baseline auscultation to final auscultation (after 1 hour)	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.
Inter-observer agreement for for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)	change from baseline auscultation to final auscultation (after 1 hour)	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.
Inter-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)	change from baseline auscultation to final auscultation (after 1 hour)	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.

Trial Locations

Locations (1)

San Pedro de Alcántara Hospital; 🇪🇸 Cáceres, Spain