Clinical Validation of Tele-stethoscope System Digital (TeleCáceres)

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

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.)

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cáceres, Spain, 10003
    • San Pedro de Alcántara Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: An open real-time tele-stethoscopy system; 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.	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.
Active Comparator: Conventional 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Investigators: Principal Investigator: Jaime Corral, MD, Hospital San Pedro de Alcántara. Cáceres. Spain

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): November 27, 2018
• Study Completion (Actual): December 27, 2018

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: e-health; Real-time; Wireless; Telemedicina; Respiratory sounds; Tele-stethoscopy; Heart sounds
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Disease; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: T-stethoscopy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No