Clinical trial NCT03596541: Clinical Validation of Tele-stethoscope System Digital
Official title: Clinical Validation of Tele-stethoscope System Digital Bluetooth Ehas-fundatel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disorder
Heart Disorder
Keywords: Telemedicina
Respiratory sounds
Tele-stethoscopy
Wireless
Real-time
e-health
Heart sounds
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.)


Eligibility criteria: 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.

Primary outcomes:
measure: Intra-observer agreement for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)
timeFrame: change from baseline auscultation to final auscultation (after 1 hour)
measure: Intra-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)
timeFrame: change from baseline auscultation to final auscultation (after 1 hour)
measure: Intra-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)
timeFrame: change from baseline auscultation to final auscultation (after 1 hour)
measure: Intra-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)
timeFrame: change from baseline auscultation to final auscultation (after 1 hour)
Secondary outcomes:
measure: Inter-observer agreement for for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)
timeFrame: change from baseline auscultation to final auscultation (after 1 hour)
measure: Inter-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)
timeFrame: change from baseline auscultation to final auscultation (after 1 hour)
measure: Inter-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)
timeFrame: change from baseline auscultation to final auscultation (after 1 hour)
measure: Inter-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)
timeFrame: change from baseline auscultation to final auscultation (after 1 hour)
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: San Pedro de Alcántara Hospital
Study officials:
affiliation: Hospital San Pedro de Alcántara. Cáceres. Spain
name: Jaime Corral, MD
role: PRINCIPAL_INVESTIGATOR
References: