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Completed

NCT Number: NCT03596541

Clinical Validation of Tele-stethoscope System Digital

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.)

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Key information

Conditions

Respiratory Disorder Cardiovascular Diseases Heart Diseases Heart Disorder Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Pedro de Alcántara Hospital

Cáceres, 10003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Intra-observer agreement for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)

    Time frame: 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.

  2. Intra-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)

    Time frame: 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.

  3. Intra-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)

    Time frame: 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.

  4. Intra-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)

    Time frame: 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 outcomes

  1. Inter-observer agreement for for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)

    Time frame: 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.

  2. Inter-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)

    Time frame: 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.

  3. Inter-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)

    Time frame: 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.

  4. Inter-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Official study title

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

Acronym: TeleCáceres

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2018
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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