Clinical Validation of Tele-stethoscope System Digital

Respiratory Disorder Clinical Trial

— TeleCáceres  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596541
• Other study ID #: T-stethoscopy
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: December 27, 2018

Study information

• Verified date: July 2022
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Heart Diseases
• Heart Disorder
• Respiration Disorders
• Respiratory Disorder
• Respiratory Tract Diseases

Intervention

Device:
• Heart 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.

Locations

Country	Name	City	State
Spain	San Pedro de Alcántara Hospital	Cáceres

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)