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Clinical Validation of Tele-stethoscope System Digital

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03596541
Acronym
TeleCáceres
Enrollment
40
Registered
2018-07-24
Start date
2018-08-27
Completion date
2018-12-27
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disorder, Respiratory Disorder

Keywords

Telemedicina, Respiratory sounds, Tele-stethoscopy, Wireless, Real-time, e-health, Heart sounds

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.)

Interventions

DEVICEHeart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)

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.

Sponsors

Sociedad Española de Neumología y Cirugía Torácica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.
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 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 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.

Secondary

MeasureTime frameDescription
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 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 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026